FDA Policy/General
The Medical Device Innovation Consortium (MDIC), of which FDA is a member, has announced a partnership with Booz Allen Hamilton to establish a benchmark of the medical device industry’s cybersecurity maturity and create resources to measure maturity over time. The benchmark will help the industry to improve product security
FDA Policy/General
Former FDA deputy commissioner for policy, legislation, and international affairs Anna Abram has joined Akin Gump as a senior advisor in its public law and policy practice. After almost four years at FDA, Abram left her role as FDA’s top policy official in January. While at FDA, Abram led
FDA Policy/General
Comments Sought Peptide Clin/Pharm Evaluations 5/14/2021 Federal Register notice: FDA has opened a public docket for comments on “Evaluating the Clinical Pharmacology of Peptides.” The agency is seeking comments on the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of
FDA Policy/General
Federal Register notice: FDA has opened a public docket for comments on “Evaluating the Clinical Pharmacology of Peptides.” The agency is seeking comments on the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of peptides as well as the effects of peptides on
FDA Policy/General
Federal Register notice: FDA has determined that Taro Pharmaceutical Industries’ Ovide (malathion) lotion, 0.5%, was not withdrawn due to safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. Ovide is
FDA Policy/General
Federal Register notice: FDA has issued an order debarring Rick Shepard for five years from importing or offering for import any drug into the U.S. Shepard was convicted 9/2020 of one felony count under federal law for conspiracy to import and introduce misbranded drugs into interstate commerce. As
FDA Policy/General
Federal Register notice: FDA has announced a 6/3-4 meeting of the Medical Devices Advisory Committee’s Neurological Devices Panel. On 6/3, the panel will discuss and make recommendations on the classification of topical refrigerants (vapocoolants), which are currently unclassified preamendment devices, to Class 2 (general and special
FDA Policy/General
Federal Register notice: FDA has announced a 6/24 Oncologic Drugs Advisory Committee that will discuss an Incyte BLA for retifanlimab injection. The proposed indication is for treating adult patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed on from or who are intolerant
Drugs
Idaho attorney general Lawrence Wasden has announced that an agreement was reached between all 50 states and Indivior that requires it to pay $300 million to settle allegations that the company falsely and aggressively marketed/promoted Suboxone (buprenorphine), which resulted in improper Medicaid expenditures. Last year, Indivior pleaded guilty to
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled M9 Biopharmaceutics Classification System-Based Biowaivers. The document provides recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of the in vivo bioequivalence (BE) study requirement for certain drug products. It is
FDA Policy/General
Federal Register notice: FDA has announced its intent to prepare an environmental impact statement (EIS) to evaluate the potential environmental effects of revised conditions for marketing certain sunscreen products for over-the-counter use without prior approval of a new drug application. The EIS is also open to public comments,
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials. The guidance was prepared under the auspices of the International Council for Harmonization to clarify, update, and extend a 1998 guidance entitled E9 Statistical
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled S11 Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals. The document provides a “weight of evidence” approach to determine when nonclinical toxicity studies may be recommended in juvenile animals. If such studies are recommended, the guidance provides
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals. The document provides key considerations for developing a testing strategy to identify hazard and characterize reproductive risk for human pharmaceuticals. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The document provides a framework to facilitate the management of post-approval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug products, including chemical
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 12 ANDAs from multiple applicants after they notified the agency in writing that the drug products were no longer marketed and requested they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Qualified Infectious Disease Product Designation — Questions and Answers. The document is intended to provide a resource for information on FDA’s policies and procedures related to the designation of a qualified infectious disease product. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled Covid-19: Developing Drugs and Biological Products for Treatment or Prevention. The document revises and replaces the final guidance of the same name issued on 5/11/2020. Revisions were made to address the evolving landscape of Covid-19
FDA Policy/General
Former FDA senior advisor for science innovation and policy Vicki Seyfert-Margolis has been named to the Penrose TherapeuTx scientific advisory board. Penrose says it focuses on developing innovative small-molecule therapies to treat advanced cancers. In addition to her tenure at FDA, Seyfert-Margolis also has extensive experience at
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution — 21 CFR Part 207” (OMB Control Number 0910-0045). The collection supports agency regulations implementing registration and listing provisions that set forth the scope, applicability,
FDA Policy/General
OMB Approves 6 FDA Information Collections 5/7/2021 Federal Register notice: FDA has announced the following information collections have been approved by OMB: * Applications for FDA Approval to Market a New Drug (0910-0001) * Medical Devices; Humanitarian Use Devices (0910-0332) * Medical Devices; Device Tracking (0910-0442) * Dispute Resolution
FDA Policy/General
Federal Register notice: FDA has announced the following information collections have been approved by OMB: * Applications for FDA Approval to Market a New Drug (0910-0001) * Medical Devices; Humanitarian Use Devices (0910-0332) * Medical Devices; Device Tracking (0910-0442) * Dispute Resolution Procedures for Science Based Decision on Products Regulated by