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FDA Introduces Annual Certification Requirement for Unchanged Drug Product Listings 

Drug establishments registered with the U.S. Food and Drug Administration (FDA) are required to renew their registrations with every year between October 1 and December 31.  The 2017 renewal period marks the first time that registered establishments must submit a “blanket no change certification” for all drug product listings that required no updates within the year.

FDA requires drug establishments to report any changes to product listings in June and December each year.  Until recently, unchanged listings required no action.  This year, registrants must certify that all product listings which were not updated have had no changes occur to the data or labeling.  Product listings that are neither updated within the year nor certified during the renewal period may be considered expired by FDA and removed from the Agency’s database.  Marketing unlisted drugs in the United States is a prohibited act.

How can I obtain “blanket no change certification” for my drug product listings?

Registered drug establishments should submit a “Blanket No Change Notification” for all products that have not been updated during the current year to certify there were no changes to the data or labeling as part of their annual registration renewal.  The notification must be submitted in structured product labeling (SPL) format.  Structuring data in SPL format requires SPL authoring software.  The SPL files can be submitted to FDA via the Agency’s Electronic Submission Gateway (ESG).  Users may also use CDERDirect to submit for human drug listings.  According to FDA, all SPL listing submissions will undergo a rigorous set of validation rules.

Registrar Corp can renew your FDA registration and certify or update your drug product listings using the required SPL format on your behalf.  Our Regulatory Specialists are experienced in navigating FDA’s ESG and can complete your renewal quickly and properly.  Contact us at +1-757-224-0177 or chat with a Regulatory Advisor online 24-hours a day at www.registrarcorp.com/livehelp.

Medical Device and Drug Establishments Must Renew FDA Registrations by December 31, 2017

Medical device and drug establishments that produce and distribute products for sale within the United States are required to renew their U.S. Food and Drug Administration (FDA) registration annually.  Registrar Corp writes to remind the industries that registrations must be renewed for 2018 between October 1, 2017 and December 31, 2017.

Medical device establishments are required to designate an Official Correspondent for FDA communications in their registrations, while drug establishments must designate a Registrant Contact. Additionally, FDA requires all businesses located outside of the United States to appoint U.S. Agents.

Notices for Medical Device Establishments

While there are no major changes this year for drug establishments, medical device businesses should be aware of two important updates for their 2018 renewals:

  1. The 2018 user fee for medical device establishment registration is $4,624, a steep increase of $1242 from 2017. All medical device establishments that are required to register must pay this fee, regardless of whether or not they qualify as a small business for other medical device user fees.
  2. As mentioned previously, foreign medical device establishments are required to designate U.S. Agents in their registrations. The 2018 renewal period marks the first time that designated U.S. Agents must verify their agreement to serve this function.  Once an Agent’s information is entered into the FDA Unified Registration and Listing System (FURLS), the system will issue them a verification email.  Agents will have ten days accept their designation through FURLS.  If a device establishment’s U.S. Agent does not accept, a new Agent must be designated or the registration may be considered invalid for 2018.

Why Timely Renewal is Important

Failure to renew FDA registration can have adverse effects.  In the past, FDA has removed establishments from its database that did not renew, rendering their registration invalid.

FDA may issue a Warning Letter to a medical device or drug business that manufactures and distributes products for interstate commerce without a valid registration.  Shipments from foreign businesses may be denied entry into the United States if their registrations are not renewed.  It is prudent for businesses to complete timely registration renewal to help avoid preventable delays from costly detentions or other enforcement actions.

Registrar Corp can assist in the renewal of your medical device or drug establishment registration, facilitate payment of fees with FDA, and issue a third-party certificate that verifies your registration. Additionally, Registrar Corp can serve as your Official Correspondent or Registrant Contact and U.S. Agent.

Renew a Medical Device Establishment Registration here.

Renew a Drug Establishment Registration here.

Alternatively, you can call us at +1-757-224-0177 or you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Publishes FY 2018 User Fees for Medical Devices and Generic Drugs

The Medical Device User Fee Amendments (MDUFA) and the Generic Drug User Fee Amendments (GDUFA) were reauthorized on August 18, 2017 to be in effect through September 30, 2022.  The U.S. Food and Drug Administration (FDA) recently published the Fiscal Year (FY) 2018 fees for both MDUFA and GDUFA, introducing new types of fees and changes in rates from FY 2017.  All MDUFA and GDUFA fees begin on October 1, 2017.  To prepare medical device and drug businesses for these requirements, Registrar Corp outlines some notable changes to these amendments this year.

Fees for medical device establishments:

MDUFA requires a user fee from medical device establishments that register with FDA, as well as fees for certain applications, notifications, and other types of submissions filed on or after October 1, 2017.  Small businesses, defined for this regulation as having less than $100 million in gross sales during the most recent tax year, are eligible for reduced rates on most fees.  All other facilities are subject to a standard fee.  Some significant changes to MDUFA for this fiscal year are explained below.

Annual Establishment Registration – All medical device establishments that are required to register with FDA must pay the Annual Establishment Registration user fee.  The fee for this year is $4,624 (a $1,242 increase from FY 2017).  Unlike with other MDUFA fees, there is no waiver or reduction for small businesses.

510(k) Application – The standard fee for 510(k) applications sees an increase of $5,876 from the FY 2017 rate of $4,690 to $10,566.  Small businesses are required to pay $2642, facing an increase of $297 from the previous year.

De Novo Classification Application – New to the recent reauthorization of MDUFA is a fee for De Novo Classification applications.  A standard business that files an application following the start of FY 2018 is required to pay $93,229, while a small business pays $23,307.

Refer to the chart below for a detailed comparison of MDUFA’s fee changes between FY 2017 and FY 2018.

 

FY 2018 MDUFA Fees

Fee Type 2017 2018
Annual Establishment Registration $3,382 $4,624
Application Fees Standard Small Business Standard Small Business
510(k) $4,690 $2,345 $10,566 $2,642
513(g) $3,166 $1,583 $4,195 $2,098
De Novo Classification N/A N/A $93,229 $23,307
PMA, PDP, PMR, BLA $234,495 $58,624 $310,764 $77,691
panel-track supplement $175,871 $43,968 $233,073 $58,268
180-day supplement $35,174 $8,794 $46,615 $11,654
real-time supplement $16,415 $4,104 $21,753 $5,438
BLA efficacy supplement $234,495 $58,624 $310,764 $77,691
PMA annual report $8,207 $2,052 $10,877 $2,719
30-day-notice $3,752 $1,876 $4,972 $2,486

 

Fees for drug establishments:

GDUFA requires user fees for certain drug establishments producing active pharmaceutical ingredients (API) or finished dosage forms (FDF), the submission of certain drug master files (DMF) for generic drug products, and the submission of certain applications for generic human drug products.  New additions to GDUFA include abbreviated new drug application (ANDA) program fees and contract manufacturing organization (CMO) facility fees.  Some significant changes to GDUFA for this fiscal year are explained below.

Contract Manufacturing Organization Fees – For the recent GDUFA reauthorization, CMO facility fees apply to FDF facilities that are identified in at least one approved ANDA, but are not the ANDA holder or an owner or affiliate of the holder.  These fees are a two-thirds reduction of FDF facility fees for qualifying establishments.  Domestic CMOs are required to pay a user fee of $70,362, while foreign CMOs pay $85,362.

ANDA User Fees – The user fee for the submission of a single abbreviated new drug application (ANDA) has increased from $70,480 to $171,823.

ANDA Program Fees – Businesses holding ANDAs are now required to pay a user fee in relation to how many they hold.  The smallest ANDA program, with as little as one approved ANDA, begins with a user fee of $159,079.  A business holding between six and nineteen approved ANDAs is required to pay a medium program fee of $636,317. The largest program fee for businesses holding twenty or more approved ANDAs is $1,590,792.

Refer to the chart below for a detailed comparison of GDUFA’s fee changes between FY 2017 and FY 2018.

 

FY 2018 GDUFA Fees

Fee Type 2017 2018
Facility Fees Domestic Foreign Domestic Foreign
API $44,234 $59,234 $45,367 $60,367
FDF $258,646 $273,646 $211,087 $226,087
CMO N/A N/A $70,362 $85,362
ANDA Program Fees – Based upon the number of approved ANDAs held
Large (20 or more ANDAs) N/A $1,590,792
Medium (6 – 19 ANDAs) N/A $636,317
Small (5 or fewer ANDAs) N/A $159,079
Application Fees
ANDA $70,480 $171,823
Type II DMF $51,140 $47,829

Not sure which user fees you may be subject to? Registrar Corp’s Regulatory Specialists can help determine your relevant fees and facilitate payment with FDA.   Call us at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Compliance Date Passed for Consumer Antiseptic Wash Final Rule

September 6th, 2017 marked the compliance date for the U.S. Food and Drug Administration’s (FDA) Consumer Antiseptic Wash Final Rule.  As of this date, over-the-counter (OTC) antiseptic washes containing any of nineteen active ingredients deemed by FDA as not “generally recognized as safe and effective” (GRASE) are not permitted to be introduced into interstate commerce without approval of a new drug application (NDA).  The rule applies to antiseptic washes intended to be used with water and does not cover products such as wipes or hand sanitizers.  Soaps, hand washes, and body washes containing these ingredients that are currently in retail establishments do not require removal, but new batches of these products may not enter the market.  You will find the list of affected ingredients below.

Why are these ingredients not GRASE?

Before the September 6 compliance date, products containing the nineteen affected ingredients were able to be marketed without approval of an NDA.  The ingredients were part of a 1994 tentative final monograph for OTC antiseptic drug products.

In 2013, FDA published a proposed rule to amend the 1994 monograph.  The Agency stated that further review of the data revealed the monograph did not sufficiently account for the health risks associated with repeated, long-term exposure to these ingredients and risks were greater than previously thought.  According to FDA, long-term exposure can have hormonal effects and can lead to the development of bacterial resistance.  In terms of effectiveness, FDA determined there was insufficient evidence that using products containing the covered ingredients was more beneficial than using products used for a comparable purpose with lower health risk (i.e. non-antibacterial soap and water).  Due to these findings, FDA deemed these nineteen ingredients “not generally recognized as safe and effective” for this intended use.

FDA has not yet made a determination on three additional active ingredients: benzalkonium chloride, benzethonium chloride, and chloroxylenol.  In March of 2017, FDA granted an additional year for interested parties to conduct studies providing further data that would support the safety and effectiveness of these ingredients.  Products using these ingredients may currently be introduced into the market, and FDA states that it may extend this time period if studies yield adequate progress.

Not sure how this rule affects your products?  Registrar Corp’s Regulatory Specialists can help determine how FDA regulates your specific antiseptic wash products and review your labeling for compliance.  For questions or assistance, call us at +1-757-224-0177. Alternatively you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Ingredients Deemed Not Generally Recognized as Safe and Effective under the Consumer Antiseptic Wash Final Rule:

Cloflucarban
Methylbenzethonium chloride
Fluorosalan
Phenol (greater than 1.5 percent)
Hexachlorophene
Phenol (less than 1.5 percent)
Hexylresorcinol
Secondary amyltricresols
Iodophors (Iodine containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Povidone-iodine 5 to 10 percent
• Undecoylium chloride iodine complex
Sodium oxychlorosene
Tribromsalan
Triclocarban
Triclosan
Triple dye

 

A Year in Review: FDA Drug and Device Regulations in 2016

Registrar Corp keeps industry up-to-date on regulations throughout the year. In 2016, the U.S. Food and Drug Administration (FDA) proposed several new regulations, including label submission requirements for certain devices, and issued extensions for compliance deadlines.

Here’s a compilation of the happenings for the drug and device industries in 2016.

  • February 18: FDA removed 771 drug facilities from the registration database due to failure to complete their annual registration renewal for 2016.
  • August 1: FDA published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017).
  • September 8: FDA issued a UDI compliance extension for certain Class II devices.
  • September 24, 2016: This marked the Unique Device Identifier (UDI) compliance date for Class II devices. Read here for tips on UDI compliance.
  • October 20: FDA proposed to require label submissions for Class II and Class III home-use devices.
  • December 21: FDA banned the use of powdered medical gloves due to the substantial risk of illness or injury to both patients and medical professionals.

In addition to the various FDA extensions, proposals, and final rules that were released over the last year, the Federal Trade Commission (FTC) issued new labeling disclaimers for homeopathic drugs.

Registrar Corp is looking forward to the new year and continuing developments in FDA regulation of the drug and device industries. For any questions about FDA drug and device regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

FTC Requiring New Labeling Disclaimers for Homeopathic Drugs

The Federal Trade Commission (FTC) recently announced a new enforcement policy for homeopathic drugs. The policy requires homeopathic drug packaging to display the following disclaimers in cases where marketers cannot adequately substantiate their claims:

  1. There is no scientific evidence that the product works.
  2. The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts

The FTC issued the enforcement policy after releasing a 24-page report that contained public comments and findings from commissioned studies. The report concluded that “customers were likely to be deceived by labels that did not carry the appropriate disclaimers.”

Prior to the new policy, homeopathic drugs were not required to prove their effectiveness or abide by U.S. Food and Drug Administration (FDA) regulations for other types of drug products. Despite being deemed by the FTC as having “no scientific evidence” to support effectiveness, homeopathic drugs have avoided regulation due to the nature of homeopathy. Homeopathy is built on the belief that small doses of substances that cause symptoms in healthy people can cure similar symptoms in unhealthy people. FDA defines a homeopathic drug as “any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.” Homeopathic drug potencies consist of substances that are diluted from 1/10 to 1/50,000 or higher.

FDA has been considering changes to homeopathic drug regulations since 2014 due to homeopathy growing into a multimillion dollar industry in the United States. In addition to the growth of the industry, homeopathic drugs have been seen to cause adverse effects on consumers.  A 2012 report showed there were 10,311 poison exposure cases related to “homeopathic agents”.  In August 2015, the FTC recommended that FDA reevaluate its regulatory framework for the regulation of homeopathic drugs after FTC research found that a significant number of consumers don’t understand:

  • Homeopathy or homeopathic products
  • How homeopathic products are regulated
  • The level of scientific evidence supporting homeopathic claims

Registrar Corp is an FDA consulting firm that helps drug companies understand and comply with FDA regulations.  For any questions about changes to homeopathic drug regulations or other current FDA regulations for drug companies, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day through Live Help.

FDA issues Final Rule on the Removal of Triclosan and Triclocarban from Antibacterial Soaps

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule on the effectiveness and safety of over-the-counter (OTC) antibacterial soaps. This final rule affects consumer antiseptic wash products for both hands and body which contain the frequently used ingredients triclosan and triclocarban as well as 17 other active ingredients (See 81 FR 61110 for a full list of eligible ingredients).  Beginning September 6, 2017, companies that manufacture and market affected antibacterial soaps may not legally introduce or deliver for introduction their products into interstate commerce unless approved under a new drug application.

FDA first proposed this rule in 2013 after research suggested that long-term use and exposure to specific active ingredients used in antibacterial soaps may cause a health risk to consumers. Examples of these health risks include hormonal effects and bacterial resistance.   According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water.”

FDA has postponed a rule making decision for consumer antiseptic soaps and washes that contain the ingredients- benzalkonium chloride, benzethonium chloride, and cloroxylenol (PCMX) for one year to allow industry to provide additional safety information. FDA will take regulatory action at that time, dependent upon whether the data provided by industry supports the conclusion that those active ingredients are generally recognized as safe and effective for this intended use.

FDA’s final rule only applies to consumer rinse-off antibacterial soaps.  This final rule does not affect consumer no-rinse handnitizers or antibacterial products used in hospital or health care settings.

Registrar Corp can help manufacturers determine whether their product is affected by FDA’s final rule.  For questions or assistance with the compliance of the final rule on antibacterial soaps, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.come/livehelp.

 

FDA Publishes FY 2017 User Fees for Devices and Generic Drugs

The U.S. Food and Drug Administration (FDA) published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017).

Medical Device User Fees for FY 2017

  • Establishment Registration Fee: $3,382 (No Reduction for Small Businesses)
  • Premarket Application (PMA, BLA, PDP): $234,495 / $58,624 for Small Businesses
  • Premarket Notification (510(k)): $4,690 / $ 2,345 for Small Businesses
  • 513(g) request for classification information: $3,166 / $1,583 for Small Businesses
  • PMA Annual Report: $8,207 / $2,052 for Small Businesses

FDA’s FY 2017 medical device user fees show a decrease from FY 2016.

Registrar Corp can register medical device establishments with U.S. FDA as well as review a 510(k) for compliance with submission requirements.

Generic Drug User Fees for FY 2017

Application Fees:

  • Abbreviated New Drug Application (ANDA): $70,480
  • Prior Approval Supplement (PAS) to an ANDA: $35,240
  • Drug Master File (DMF): $51,140

Facility Fees:

  • Active Pharmaceutical Ingredient (API)—Domestic: $44,234
  • API—Foreign: $59,234
  • Finished Dosage Form (FDF)—Domestic: $258,646
  • FDF—Foreign: $273,646

FDA’s FY 2017 ANDA and PAS application fees show a decrease from FY 2016.   The FY 2017 DMF application fee as well as the API and FDF facility fees show an increase from FY 2016.

Registrar Corp can register a drug establishment and file DMFs with U.S. FDA.

Filing in ACE for FDA: Compliance Dates and Common Errors

On June 9, 2016, the U.S. Customs and Border Protection (CBP) hosted a webinar on filing import entries through the Automated Commercial Environment (ACE) portal.  The webinar was organized by the U.S. Food and Drug Administration (FDA) and the National Customs Brokers and Forwarders Association of America (NCBFAA).

What is ACE?

Customs brokers and self-filing importers must file information with CBP and other agencies regarding products they import into the United States. CBP describes ACE as “the primary system through which the trade community will report imports and exports and the government will determine admissibility.” CBP and FDA, along with 46 other government agencies, have partnered to make ACE a single window for submitting all data required by the agencies.  ACE will replace ACS, the current commercial database used to submit data through CPB to FDA.

Compliance Dates

June 15, 2016 is the date when ACE is to become the sole filing system for the following FDA entry types:

  • 01 – Consumption – Free and Dutiable
  • 03 – Consumption – Antidumping/Countervailing Duty
  • 06 – Consumption – Foreign Trade Zone (FTZ)
  • 11 – Informal – Free and Dutiable
  • 23 – Temporary Importation Bond (TIB)
  • 51 – Defense Contract Administration Service Region (DCASR)
  • 52 – Government – Dutiable

While June 15 acts as the mandatory filing date for these FDA entry types, CBP is allowing a sort of learning period through July 23, 2016.  Entries filed through ACS after June 15 will likely be allowed, but the consequences will be decided on a case-by-case basis.  Users may receive a warning message.  CBP may also follow up with ACS filers to see why they are not filing through ACE and to determine how CBP can assist in the transition to ACE.  Come July 23, ACS will no longer be allowed as an alternate filing method.

Common Errors when Filing in ACE

During the webinar, FDA revealed some of the most common errors and causes for entry rejection made when filing entries through ACE.

  • Filers must provide a valid prior notice confirmation number for food and beverage shipments. Filers should only include the confirmation number and not the other FDA data required to file prior notice. Many filers submit invalid prior notice confirmation numbers.
  • Many filers fail to provide a valid FDA registration number. (Tip: FDA requires food facilities to renew their FDA registration between October 1 and December 31 of each even-numbered year. Registrations not renewed as required are considered expired by FDA.)
  • Many entries are rejected for a missing or invalid product code, affirmation of compliance code, or intended use code.
  • Many filers include mismatching entity IDs. For example, an entry for a processed food must list a manufacturer code (as opposed to a grower code) as the entity ID.
  • Many filers include mismatching source type codes. Entries for imports from growers or consolidators must list a country of growth, while entries for imports from manufacturers of processed foods must list a country ofproduction. Both types of entries must also include a country of shipment.
  • Many filers list a foreign country as the ultimate consignee for non-food items. This is incorrect, as the ultimate consignee is meant to represent the final destination where the product will be delivered within the United States.

These are but a few of the mistakes made when filing entries within ACE.  FDA offers assistance with ACE entries at[email protected]. FDA ACE support will be available 24/7 beginning sometime this month.  FDA also provides this chart for identifying required data elements for entries of FDA-regualated products.

If you notice a mistake in an ACE entry, you may submit corrections up to 5 days before a shipment’s expected arrival to the United States.  Once the shipment is within 5 days of its expected arrival, no corrections may be made unless FDA rejects the entry.

Speeding Up Your Imports

It’s prudent for brokers and importers to begin filing their entries through ACE as early as possible, as ACE provides the quickest entry. According to FDA, the agency is actively prioritizing ACE entries over those filed through ACS.  Entries filed through ACE are processed two times faster.

While DUNS and FEI numbers are not currently required for filing entries of most commodities in ACE, FDA noted that including this data may expedite the processing of an entry.  “Providing a DUNS number gives FDA a higher confidence level in looking at that data,” the agency said during the webinar regarding confirming the name and address of a product manufacturer.

How Registrar Corp can Assist

Registrar Corp offers a variety of services to help brokers obtain the information they need to file entries in ACE.  Registrar Corp can:

Registrar Corp’s FDA Compliance Monitor also acts as a valuable resource for custom brokers and importers.  The monitor provides detailed information on monitor facilities, such as a facility’s DUNS number (when available) and any FDA Warning Letters, Import Alerts, Import Refusals, and Inspection Classifications tied to the facility.

For more information on filing FDA-regulated entries in ACE, regulations for importing FDA-regulated products to the United States, or how Registrar Corp can assist, contact +1-757-224-0177.  Live help is available 24-hours a day at www.registrarcorp.com/livehelp.





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