FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act. The document describes how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act to human drug products
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Medical Device Labeling Regulations” (OMB Control No. 0910-0485). The collection supports medical device labeling requirements governed by section 502 of the Federal Food, Drug, and Cosmetic Act. Device labeling requirements provide for the label or labeling
FDA Policy/General
The Biden Administration is nearing its choice of a nominee for FDA commissioner. Addressing reporters on 10/5, president Biden was asked whether he had chosen someone for the agency‘s top job. “We’ll be talking about that in a little bit,” he responded. The Biden Administration reportedly has
FDA Policy/General
Immunicom has named Christian Shenouda, who worked at FDA in both CDER and CDRH, as vice president of regulatory affairs to develop and execute a regulatory strategy to integrate its Immunopheresis therapy into standard medical practice. A company statement says Immunicom “expects streamlined regulatory approval for the Immunopheresis therapy under
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs. The document describes FDA’s current thinking on incorporating real-world data and real-world evidence (including ongoing surveillance activities, observational studies,
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs. The document addresses incorporating data from foreign countries into proposed clinical investigational protocols and applications for new animal drugs. to view the notice, click
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs. The document describes FDA’s current thinking on incorporating complex adaptive and other novel investigation designs into proposed clinical investigation protocols and applications for new animal drugs.
FDA Policy/General
Center for Veterinary Medicine (CVM) director Steven Solomon says FDA has released four final guidances describing pathways for animal drug sponsors to use new approaches like adaptive study designs, real-world evidence, and biomarkers to establish drug effectiveness. The documents also offer more detailed guidance on how to leverage data
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals. The International Council for Harmonization document expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach that is not described in
FDA Policy/General
Federal Register notice: FDA is withdrawing a 9/30 notice that announced in error the issuance of a priority review voucher to a rare pediatric disease product sponsor. In the withdrawn notice, the agency wrongly determined that a Enzyvant Therapeutics BLA Rethymic (allogeneic processed thymus tissue-agdc) met criteria for
FDA Policy/General
Federal Register notice: FDA has updated its listing of available guidance documents related to the Covid-19 public health emergency. Periodic updates are pursuant to the process that FDA announced 3/2020 for making guidances available during the pandemic. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced an 11/19 public workshop entitled “Best Practices for Development and Application of Disease Progression Models.” The workshop is intended to discuss the best practices for developing disease progression models and their application to support drug development decisions. It will also share case studies
FDA Policy/General
Federal Register notice: FDA is correcting a notice that appeared in the 6/25 Federal Register and announced the approval withdrawal of 36 ANDAs from multiple applicants. Yung Shin Pharmaceutical subsequently notified the agency about not withdrawing ANDA 065152, cephalexin capsules, and this notice states its approval is still in
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities” (OMB Control Number 0910-0883). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Electronic User Fee Payment Request Forms — Form FDA 3913 and Form FDA 3914 (OMB Control Number 0910-0805). Form FDA 3913, User Fee Payment Refund Request, is designed to provide information for FDA to review and process
FDA Policy/General
Federal Register notice: FDA has announced that 23 information collections have been approved by OMB. They are: * Blood Establishment Registration and Product Listing for Manufacturers of Blood and Blood Products and Licensed Devices * Current Good Manufacturing Practice: Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals * Irradiation in
FDA Policy/General
Draft Guide on Investigator Safety Reporting 9/30/2021 Federal Register notice: FDA has released a draft guidance entitled Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices. The document is intended to help clinical investigators to identify safety information that is considered an unanticipated problem involving risk to human
FDA Policy/General
China-based 3SBio Inc. has entered into an asset purchase agreement with Canada-based biologics manufacturer Therapure Biopharma Inc. to acquire its contract development and manufacturing business for $290 million. The acquisition is intended to allow 3SBio improve its connections with global biotechnology and pharmaceutical companies in order to form
FDA Policy/General
DEVICES FDA has approved Grifols’ Procleix Zika Virus assay for detecting the virus in individual or pooled plasma specimens from human donors, including volunteer donors of whole blood and blood components for transfusion. The assay is also approved for testing plasma or serum specimens to screen other living (heart-beating)
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. The document is intended to provide sponsors, researchers, and other interested stakeholders with considerations when proposing to use
FDA Policy/General
Federal Register notice: FDA has extended the comment period for the notice entitled Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments that appeared in the 8/9 Federal Register. A 4/16 decision affirmed a district court ruling that FDA is not afforded discretion
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial. The document addresses how sponsors can gather preliminary evidence of safety and activity using multiple versions of a cellular or gene therapy product