Latest Federal Register Notices

BIOLOGICS

Draft Guide on Biosimilar Interchangeability
Federal Register Notice: FDA has made available a draft guidance for industry entitled “Considerations in Demonstrating Interchangeability With a Reference Product.” The document is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act. The guidance is one in a series of guidances that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009. To view the notice, click here.

DEVICES

Comments Sought on MEDSUN Information Collection
Federal Register Notice: FDA is seeking comments on an information collection extension for its “Adverse Event Program for Medical Devices (Medical Product Safety Network — MEDSUN).” FDA is seeking OMB clearance to continue to use electronic data collection to obtain the information on Form FDA 3500A related to medical devices and tissue products from user facilities participating in MedSun, to obtain a demographic profile of the facilities, and for additional questions which will permit it to better understand the cause of reported adverse events. To view the notice, click here.

DRUGS

Panel Meeting on Neurocrine Bio NDA Canceled
Federal Register Notice: FDA has canceled a 2/16-planned Psychopharmacologic Drugs Advisory Committee meeting that was announced in the 12/27/2016 Federal Register. Panel members were scheduled to review a Neurocrine Biosciences NDA for valbenazine 40 milligram (mg) capsules, indicated for treating Tardive Dyskinesia. To view the notice, click here.

Guidance on Assessing Abuse Potential Drugs
Federal Register Notice: FDA has made available a guidance entitled “Assessment of Abuse Potential of Drugs.” The document is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their new drug product has abuse potential. Specifically, it provides recommendations for assessing the abuse potential of central nervous system (CNS)-active new drugs. Thus, if a drug substance is CNS-active, the new drug product containing that drug substance will likely need to undergo a thorough assessment of its abuse potential and may be subject to control under the Controlled Substances Act. To view the notice, click here.

Draft Guide on ANDAs for Drug-Device Combo Products
Federal Register Notice: FDA has made available a draft guidance on “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” The document provides recommendations that focus on the analysis of the proposed user interface for any proposed generic drug-device combination product when compared to the user interface for the reference listed drug (RLD). This includes the delivery device constituent part of the combination product and any associated controls and displays, as well as product labeling and packaging. To view the guidance, click here. To view the notice, click here.

FDA GENERAL

Draft Guide on Communication to Payors, Formularies
Federal Register Notice: FDA has made available a draft guidance for “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers.” The guidance provides answers to common questions on communicating health care economic information about approved prescription drugs by medical product manufacturers, packers, distributors, and their representatives to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis. The document also provides answers to common questions about firms’ communications regarding investigational drugs and devices to payors before FDA approval or clearance of such products. To view the notice, click here.

Draft Guide on Product Communications Consistent with Labeling
Federal Register Notice: FDA has made available a draft guidance on “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers.” The document provides information for manufacturers, packers, and distributors of drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs, about how FDA evaluates their medical product communications, including their promotional materials, that present information that is not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product. To view the notice, click here.

Comment Period Reopened and New Memo on Off-label Communications
Federal Register Notice: FDA has reopened the comment period concerning its comprehensive review of regulations and policies governing manufacturer communications about unapproved uses of approved or cleared medical products. The agency has also made available “Memorandum: Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” that provides additional background on the issues it is considering as part of its comprehensive review, including a discussion of First Amendment considerations. To view the notice, click here.