Drugs
FDA has posted summaries of the 12/9/20 and 12/16/20 meetings of the FDA/industry pre-market subgroup that is part of discussions on the PDUFA 7 reauthorization. The 12/9 meeting covered: * further discussions about a real-world evidence pilot program to increase the use of
Drugs
Two consultants say that it usually is not FDA that slows the approval process for NDAs and BLAs. Writing in a Stat opinion piece, Certara CEO William Feehery and vice president Julie Bullock, a former FDA clinical pharmacology reviewer, say the main reason for delays and extensions is that sponsors
Biologics
FDA reviewers are backing an emergency use authorization (EUA) for Janssen Biotech’s single intramuscular Covid-19 vaccine injection. In briefing materials released in advance of a 2/26 advisory committee meeting discussing the vaccine’s EUA request, agency reviewers determined that the vaccine “met the prespecified success criteria” in
Drugs
FDA has revised its 9/1/20 guidance, Control of N-Nitrosamine Impurities in Human Drugs, to extend to 3/31 from 3/1 the recommended timeframe for completing risk assessments. FDA says manufacturers do not need to submit risk assessment documents to the agency, but should retain them so
Drugs
CDER has published a revised Manual of Policies and Procedures (MAPP) describing the organization, membership, responsibilities, and procedures for the Medical Policy Council (MPC). The MAPP says the MPC will provide senior support to CDER on medical policy development including: * leadership oversight and medical policy management for the Center; * attention
Drugs
The Sedgwick Brand Protection State of the Nation 2021 report predicts that by mid- to late-2021 FDA will start revoking medical device emergency use authorizations, reverting to unapproved status devices that were not approved by regular means. The report cautions that legal protections currently offered to manufacturers and distributors
Devices
FDA has granted Dascena a breakthrough device designation for its GI Bleed Risk Alert System (Gibras), a cloud-based software application that uses a machine learning algorithm to analyze patient electronic health record data to aid in the early prediction of gastrointestinal bleeding (GIB) in adult patients in a hospital
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices” (OMB Control Number 0910-0577). The collection is related to Section 502 of the Federal Food, Drug, and Cosmetic Act that establishes requirements that a label or labeling
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics” (OMB Control Number 0910-0850). The collection is related to an agency guidance under the same title that
FDA Policy/General
Federal Register notice: FDA is seeking comments on an upcoming workshop (date undetermined) on advancing model-informed drug development. The workshop is intended to discuss best practices for developing disease progression models and their application to support drug development decisions; share experiences and case studies that highlight the opportunities and
Drugs
FDA has accepted for priority review a Pfizer BLA for TicoVac, its tick-borne encephalitis (TBE) vaccine for use in individuals one year of age and older. The company says it expects a user fee review action in August. TBE is a brain/spine viral infection that is transmitted to
Drugs
FDA has denied Sun Pharma’s appeal of the complete response letter the agency issued for Sun’s NDA for Taclantis (PICS), a novel formulation of paclitaxel under development to treat breast cancer. India’s Economic Times reports that FDA asked the company to conduct a new Phase 3 study
Drugs
An online FDA post says the agency is advising compounders and healthcare providers that it has concerns about the use of certain drugs prepared by compounders to treat patients with Covid-19. The post lists these concerns: * Thymosin-alpha 1 is not a component of an approved drug and thymosin
Drugs
Over-the-counter drug monograph reform will take more than a few years to implement, given some of the timeframes for publication of a non-binding list of OTC monographs discussed in a 1/27 agency Webinar on monograph reform. Attorney Carolina Wirth (Arnall Golden Gregory) says the agency also
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (Covid–19). The document is intended to alert pharmaceutical manufacturers and pharmacists in state- licensed pharmacies or federal facilities who engage in
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a 1/11 notice requesting comments regarding 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.” Electronic or written comments can now be submitted
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Adverse Experience Reporting for Licensed Biological Products and General Records — 21 CFR Part 600” (OMB Control Number 0910-0308). Agency regulation requires licensed manufacturers or any person whose name appears on the label of a licensed biological
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a CooperSurgical direct-to-consumer video for Paragard (intrauterine copper contraceptive) is false and misleading by presenting efficacy claims for Paragard and failing to communicate any risk information associated with its use. A 2/12 Warning Letter says the video was
Drugs
FDA has denied a 2/26/18 Synergy Pharmaceuticals petition asking that the agency require specified revisions to the approved package insert for Forest Laboratories’ Linzess (linaclotide) capsules. The petition asked that FDA: * convert the Trial 5 safety data for the Linzess 72 mcg dose in patients treated for chronic
FDA Policy/General
Former FDA commissioner Stephen Hahn has joined clinical therapeutics Blackfynn’s board of directors. The firm says its approach to drug development is “grounded in its roots as a technology and data analysis company focused on neurodegenerative diseases. Blackfynn’s business model is to acquire and complete the development of
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Shortages Data Collections” (OMB Control Number 0910-0491). The agency’s regulations give CDRH authority to acquire and maintain detailed data on domestic inventory, manufacturing capabilities, distribution plans, and raw material constraints for medical devices that would
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. CooperSurgical, Trumbull, CT (2/12): CDER’s Office of Prescription Drug Promotion (OPDP) cited the firm’s direct-to-consumer video for Paragard (intrauterine copper contraceptive) as false and