October 2019 Drug and Device Corner

REMINDER: we are currently in the renewal period (1 Oct – 31 Dec) for medical device & drug establishment registrations, as well as drug listing certifications.

The FDA, in their commitment to assisting industry in the development of affordable, available, generic drugs, and as part of the Drug Competition Action Plan, is working toward addressing and improving transparency with regard to potential generic applicants obtaining brand RLD samples for generic drug development. The significant issue of industry’s inability to obtain certain RLDs for generic drug development, those that are in limited distribution, is being addressed by the agency in part by posting a list identifying all drug products for which the FDA has received an RLD access inquiry related to limited distribution. Further information is available on the website.

In the October 25, 2019 issue of the Federal Register, FDA announced that it was withdrawing Compliance Policy Guide Sec. 400.400 “Conditions under Which Homeopathic Drug Products May be Marketed”, effective immediately. This CPG was issued in 1988 and has served as the mechanism by which the regulation of homeopathic drug products was enforced.

However, due to ongoing concerns about the safety of homeopathic drug products, the FDA determined that the CPG did not prevent unsafe products from reaching the market nor did it reflect the agency’s current thinking with regard to its risk-based approach to regulatory and enforcement action.

In addition to withdrawing the CPG, the FDA also revised the draft guidance Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry that had been issued in 2017. The revised draft adds a definition for “homeopathic drug product”, incorporates additional information regarding safety issues that contributed to the development of the guidance and clarifies the agency’s intent to use risk-based factors to prioritize enforcement and regulatory actions involving homeopathic drug products.

In an effort to assist Applicants with supplying correct and complete facility information to the FDA for NDAs, ANDAs, BLAs and submissions associated to these applications, the FDA has published the Guidance Document Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Q & A. This guidance is intended to clarify Agency expectations regarding facility information that should be included in original NDAs; ANDAs; original BLAs; amendments; supplements; CMC supplements; and resubmissions to these submission types. It is the FDAs hope that this guidance document will reduce the frequency of IRs, RTFs and RTRs as well as increase the efficiency of the application assessment process. The document addresses form 356h, Module 3 and referenced DMF details.

Federal Register Vol 84, No 207, Medical Devices; Exemptions from Premarket Notification: Class II Devices; Request for Comments. FDA is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). FR Vol 84, No 206, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 052” (Recognition List Number: 052), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

Quarterly Inactive Ingredient Database (IID) Change Log

Guidance Document updates on the FDA website:

ALL DIVISIONS:

CDER:

CDER & CBER:

CDRH:

CBER:

CVM:

Posted in 2019, 2019 November, Drug and Device Corner, EASeNews.