FDA Policy/General
Federal Register notice: FDA is requesting comments on a document entitled “Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper.” The paper outlines a potential framework for how sponsors of new animal drug products containing medically important
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on CDRH’s National Mammography Quality Assurance Advisory Committee notify it in writing. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed “Collection of Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.” The collection supports FDA intramural training programs through fellowship and traineeship programs. These mandatory collection forms provide FDA with information from the non-employee to: (1) Begin
FDA Policy/General
Federal Register notice: FDA has determined that 20 drug products (detailed below) were not withdrawn from sale for reasons of safety or effectiveness. The determination means that the agency will continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. Affected
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for a notice that appeared in the 7/31/2020 Federal Register in which FDA identified certain bulk drug substances (active pharmaceutical ingredients) that it has considered and proposes to include or not include on the list of bulk drug substances
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “FDA Recall Regulations — 21 CFR Part 7” (OMB Control Number 0910-0249). The collection helps support implementation of Section 701 of the Federal Food, Drug, and Cosmetic Act (21 USC 371) pertaining to product recalls, and regulations
FDA Policy/General
Federal Register notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and nonvoting consumer representatives to serve on advisory committees
FDA Policy/General
Federal Register notice: FDA has issued an order to permanently debar former Insys Therapeutics regional sales manager Joseph A. Rowan from providing services in any capacity to a person that has an approved or pending drug product application. Last year, he was convicted of engaging in a conspiracy whereby Insys
FDA Policy/General
Federal Register notice: FDA has issued an order to permanently debar former Insys Therapeutics regional sales manager Sunrise Lee from providing services in any capacity to a person that has an approved or pending drug product application. Last year, she was convicted of engaging in a conspiracy whereby Insys employees
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Safer Technologies Program for Medical Devices. The document describes a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Human Gene Therapy for Neurodegenerative Diseases. The document provides recommendations for sponsors developing human gene therapy products for neurodegenerative diseases affecting adult and pediatric patients. It defines neurogenerative diseases as a heterogeneous group of disorders characterized by progressive degeneration
FDA Policy/General
Former CDER director Janet Woodcock, who has been on detail at the White House’s Operation Warp Speed (OWS), has moved to the Office of Commissioner to serve as principal medical advisor to the commissioner while also continuing her role with OWS. The move came at commissioner Stephen Hahn’s
FDA Policy/General
Federal Register notice: FDA is withdrawing a 12/29 Federal Register notice entitled “Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fiscal Year 2021” because FDA lacked the delegated authority to issue the notice. HHS has ordered FDA to cease further collection efforts related to the
FDA Policy/General
Federal Register notice: FDA has issued an order to permanently debar former Insys Therapeutics regional sales manager Alec Burlakoff from providing services in any capacity to a person that has an approved or pending drug product application. Last year, he was convicted of engaging in multiple acts of illegal distribution
FDA Policy/General
Federal Register notice: FDA has issued an order to permanently debarring former Cumberland Distribution owner Jerrod Nichols Smith from providing services in any capacity to a person that has an approved or pending drug product application. Smith recently was convicted of violations related to wholesale drug distribution. To view the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations. The document is intended to help sponsors develop such products for treating severely debilitating or life-threatening genetic disease. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Mouse Embryo Assay for Assisted Reproduction Technology Devices. The document provides recommendations on conducting the mouse embryo assay to support premarket submissions and lot release of assisted reproduction technology devices. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Coco’s Holistic Specialties & Apothecary (1/4): FDA recently reviewed the firm’s Web site (https://cocosholisticspecialties.org) and determined that it is marketing unapproved and misbranded products
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300” (OMB Control Number 0910-0633). To view the notice, click here.
FDA Policy/General
The follow are the Federal Register notices published the week ending 1/01/2021: Federal Register notice: FDA has announced the renewal of the Cellular, Tissue and Gene Therapies Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/
FDA Policy/General
The follow are the Federal Register notices published the week ending 12/25/2020: Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Export of Food and Drug Administration-Regulated Products: Export Certificates” (OMB Control Number 0910-0498). To view the notice, click here. Federal Register
FDA Policy/General
FDA has posted the latest Warning Letters posted the weeks ending 12/25/2020 and 1/1/2021. They can be accessed by clicking on the link following each letter. Clientele, Sunrise, FL (12/3/2020): FDA inspected the firm in February 2020 and cited significant GMP violations for finished