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Sunscreen Innovation Act to Enhance Product Safety Requirements

On February 21, 2019 FDA issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States. Aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science, the provisions address sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information.

Per FDA, the agency is issuing this proposed rule to put into effect final monograph regulations for OTC sunscreen drug products as required by the Sunscreen Innovation Act. OTC monographs establish conditions under which the FDA permits certain OTC drugs to be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded. Over the last twenty years, new scientific evidence has helped to shape the FDA’s perspective on the conditions, including active ingredients and dosage forms, under which sunscreens could be considered GRASE. For more information, please visit: Sunscreen Proposed Rule

You may also be interested in EAS complimentary webinar series on OTCs which includes a discussion of monograph reform expectations, labeling, registrations and lists and more. For more information please visit the upcoming webinars page on the EAS website or view our many on-demand webinars on a variety of topics pertinent to the industry.

Federal court enters consent decree against compound manufacturer

The FDA is continuing to see concerning activity when it comes to some compounded drugs, including problems related to the conditions under which compounded sterile medicines are made. As a result, the FDA continues intense focus in this area. The FDA will take enforcement actions against compounders who fail to produce sterile drugs in compliance with FDA regulations.

A consent decree of permanent injunction was filed against a company and its owner. The consent decree prohibits the company and its owner from, among other things, manufacturing, holding, or distributing human or animal sterile drugs compounded at their facility until they comply with the Federal FD&C Act and FDA regulations.

The complaint was filed by the U.S. Department of Justice on behalf of the FDA. Further information can be found on the FDA website.

Medical Device Classification Procedures

The FDA issued a final rule on the classification procedures for medical devices on 17th December, 2018 entitled “Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures”. The rule will be effective from March 18th, 2019.

The purpose of this final rule is to incorporate the amendments by Food and Drug Administration Safety and Innovation Act (FDASIA) to the FD&C Act which governs the classification and reclassification of medical devices. Also, additional changes have been made by the FDA independent of the FDASIA in efforts to update its regulations governing classification and reclassification of medical devices. The rule will enhance consistency and uniformity across reclassification processes and will also help to reduce regulatory and economic burden.

Summary of the major provisions of the final rule include the provisions for reclassification of devices and for requiring PMA applications for preamendments class III devices to change from a rulemaking proceeding to an administrative order process. Prior to publication of a final order reclassifying a device or requiring a PMA application for a preamendments class III device, FDA must publish a proposed order in the Federal Register, consider any comments submitted on the proposed order, and hold a device classification panel meeting. This final rule also clarifies the process where reclassification of a postamendments device or a transitional device is initiated by FDA, rather than in response to a petition. The final rule also removes the requirement for a hearing under part 16 (21 CFR part 16) for reclassifying transitional devices.

More information can be found at regulations.gov

Guidance Document updates on the FDA website

Guidance Document highlight

In order to improve communications regarding corrective actions in response to inspectional observations with medical device companies, the FDA issued a draft guidance titled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments”, a requirement under the FDA Reauthorization Act of 2017 (FDARA). The document was issued on February 19th, 2019.

Earlier, companies could ask for a feedback on proposed corrective actions but there was no standardized process in place for provision of nonbinding feedback. The draft guidance proposes to standardize the process of communicating and submitting nonbinding feedback for companies on certain kinds of documented inspectional observations that are issued on a Form 483, during either premarket or postmarket inspections of device establishments. It also describes how the FDA evaluates and responds to such requests.

The proposed guidance has outlined steps on the process of requesting a nonbinding feedback.

These include timely submission of request, eligibility criteria, justification of request, proposed responsive actions and how the FDA will respond with a nonbinding feedback. More detailed description can be found here.


Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry Draft guidance document for sponsors who are developing drugs and therapeutic biologics for Eosinophilic Esophagitis (EoE) stating FDA’s current recommendations regarding clinical trials for EoE drugs.

Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment Guidance on FDA’s current thinking about drug product development and designing of trials relevant to study of depot buprenorphine products for Opioid Use Disorder treatment through 505(b)2 pathway for a new drug application (NDA) submission

Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format Guidance for Industry Draft guidance document intended to assist holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) approved under section 505(c) and 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(c) and (j)), respectively with identifying required contents for marketing status notification and format to submit these notifications required under section 506I of the FD&C Act (21 U.S.C. 356i)

Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Product This guidance is intended to encourage manufacturers of medically necessary drug products (MNPs) and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities.

CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality This guidance describes a proposed program at FDA’s Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality. CDER is issuing this draft guidance to obtain public comments on the proposed program.

Competitive Generic Therapies This guidance provides a description of the process that applicants should follow to request designation of a drug as a CGT and the criteria for designating a drug as a CGT. This guidance also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs. This guidance also provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs.

Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products The purpose of this guidance is to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products, including but not limited to those intended to help cigarette smokers stop smoking. This guidance reflects the FDA’s current recommendations regarding overall development programs to support NRT drug products for smoking cessation and related chronic indications.


Safety and Performance Based Pathway – Guidance for Industry and Food and Drug Administration This guidance provides FDA’s current thinking on expanding the concept of the Abbreviated 510(k) Program for demonstrating substantial equivalence for premarket notification (510(k)) submissions

The Least Burdensome Provisions: Concept and Principles – Guidance for Industry and FDA Staff

Rare Diseases: Common Issues in Drug Development Guidance for Industry Rev. 1 Draft guidance is to assist sponsors of drug and biological products for the treatment or prevention of rare diseases in conducting more efficient and successful drug development programs.

Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) The PMA regulation (21 CFR 814.42(e)) identifies the criteria that, if not met, may serve as a basis for refusing to file a PMA. This guidance is intended to be used by FDA staff and the device industry to help elucidate the broad preclinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process.


Evaluation of Devices Used with Regenerative Medicine Advanced Therapies This guidance provides manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with FDA’s current thinking regarding evaluation of devices used in the recovery, isolation, or delivery of regenerative medicine advanced therapies.

Refuse to Accept Policy for 510(k)s The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.


Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Guidance for Industry and Food and Drug Administration Staff This guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST).


Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements † This guidance describes the Food and Drug Administration’s (FDA) intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved criteria of section 510(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 360(l), from premarket notification requirements.


Expedited Programs for Regenerative Medicine Therapies for Serious Conditions This guidance addresses regenerative medicine therapies which are defined in section 506(g)(8) of the FD&C Act as including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products, except for those regulated solely under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264) and Title 21 of the Code of Federal Regulations Part 1271 (21 CFR Part 1271).

The 21st Century Cures Act (Cures), signed into law on December 13, 2016, amended several sections of the Federal Food, Drug, and Cosmetic Act. This guidance was developed and issued prior to the enactment of Cures, and certain sections of this guidance may no longer be current as a result. FDA is assessing how to revise this guidance to represent our current thinking on this topic. For more information please contact DICE@fda.hhs.gov.

Posted in Drug and Device Corner, Drugs, Medical Devices.