Biologics
The DC federal court has approved an FDA request to stay its response to a Children’s Health Defense Freedom of Information Act (FOIA) request for records connected with the safety monitoring of Covid-19 vaccines through the VAERS (Vaccine Adverse Event Reporting System) database. But it cut the requested
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.” The International Council for Harmonization document is intended to describe risk-based principles and mitigation strategies to assure the viral safety of
Drugs
The Washington Legal Foundation (WLF) says an FDA draft guidance on communications from firms to healthcare providers about scientific information on unapproved uses (SIUU) of approved/cleared medical products “threatens to undermine public health” and also “disregards the Constitution.” The WLF comment letter says the draft would chill truthful, non-
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Requests for Reconsideration at the Division Level Under GDUFA.” The document provides recommendations on the procedures for ANDA applicants that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled Electronic Records; Electronic Signatures — 21 CFR Part 11.The collection supports statutory and regulatory authorities that govern criteria for accepting electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records. The
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of a priority review voucher to Takeda Pharmaceuticals for its qualified rare pediatric disease product application — Adzynma (ADAMTS13, recombinant-krhn), indicated for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura. To view the
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of a priority review voucher to Amryt Pharmaceuticals for its qualified rare pediatric disease product application — Filsuvez (birch triterpenes), indicated for treating partial thickness wounds in patients six months and older with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa. To view the
FDA Policy/General
A staff announcement from CDER director Patrizia Cavazzoni says that FDA commissioner Robert Califf has selected Elizabeth “EJ” Jungman to be his chief of staff. She is currently the director of the CDER Office of Regulatory Policy (ORP). Cavazzoni said the new appointment “is a recognition of EJ’s broad
FDA Policy/General
Federal Register notice: FDA is announcing that it issued a priority review voucher (pediatric disease product) to Vertex Pharmaceuticals for gaining approval of Casgevy (exagamglogene autotemcel), indicated for treating sickle cell disease in patients 12 years and older with recurrent vaso-occlusive crises. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Expedited Programs for Serious Conditions — Drugs and Biologics.” The collection supports regulations governing the agency’s expedited programs intended to speed the availability of new therapies to patients with serious conditions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft document entitled “Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance.” The document is mandated by the Consolidated Appropriations Act of 2023, directing the agency to identify best practices for the efficient prioritization, development, issuance, and
FDA Policy/General
Public Citizen says Dr. Sidney Wolfe, the founder of the Health Research Group in 1971, which later that year became part of Public Citizen, died 1/1 at the age of 86. “Sid invented a new approach of research-based advocacy to get dangerous drugs and devices off the market,
FDA Policy/General
The U.S. House Energy and Commerce Committee’s Republican leadership is investigating FDA’s handling of internal scientific disagreements related to regulatory decisions. In a 1/3 letter to agency commissioner Robert Califf, Committee leaders took issue with the 2021 departure of CBER Office of Vaccines Research and Review
FDA Policy/General
FDA has published a guidance, Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers, to help small entities understand and comply with the standards established in that final rule.
FDA Policy/General
FDA Webview has summarized below the Federal Register notices published during our holiday break. 12/28/2023 Federal Register notice: FDA is making available a draft guidance entitled “Potency Assurance for Cellular and Gene Therapy Products.” The document provides quality risk management recommendations to help assure the potency of human
FDA Policy/General
FDA has published a guidance, Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species. The document outlines the basic requirements and special considerations for approval of new animal drugs intended for minor uses in major species or for use
FDA Policy/General
Ferdic, Inc., publisher of Dickinson's FDA Webview, wishes all readers Happy Holidays and a bright and prosperous New Year. Our newsroom is closed until Tuesday, January 2, 2024.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of the indications for mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) for Pharmacyclics Imbruvica (ibrutinib) capsules and tablets that were approved, respectively, under NDAs 205552 and 210563. The action follows the company’s decision earlier this year to voluntarily withdraw the
FDA Policy/General
Federal Register notice: FDA has sent to OMB an information collection proposal entitled “A Survey on Quantitative Claims in Direct-to-Consumer (DTC) Prescription Drug Advertising.” DTC prescription drug advertising may make quantitative claims about a drug’s efficacy or risks, and the agency has research and guidance available that
FDA Policy/General
FDA has released a draft guidance entitled “Priority Zoonotic Animal Drug (PZAD) Designation and Review Process.” FDA says that a PZAD is defined as a “new animal drug, that alone or in combination with one or more other animal drugs, has the potential to prevent or treat a zoonotic disease
FDA Policy/General
FDA has sent Warning Letters to nine manufacturers and distributors of unapproved and misbranded antimicrobial animal drugs. An agency statement says FDA is concerned because the products contain antimicrobials that are important in human medicine. Using them without medical oversight contributes to the development of antimicrobial resistance, it says. The
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Adam Michael Nagy for a period of 15 years from importing any drug into the U.S. FDA based the action on Nagy’s conviction related to illegally importing Schedule I and II drugs while he was the owner and operator