Biologics
FDA has amended the emergency use authorizations for Moderna’s Covid-19 vaccine and Pfizer-BioNTech’s Covid-19 vaccine to allow their use in children as young as six months of age. The Moderna vaccine is administered as a primary series of two doses, one month apart, to individuals
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A” (OMB Control Number 0910–0458). To view the notice, click here.
Drugs
The Federal Trade Commission says it is ramping up enforcement against any illegal bribes and rebate schemes that impede patients’ access to competing lower-cost drugs. Drug companies use rebates to have their drugs placed on formularies or on preferred tiers of formularies to ensure those drugs are covered. FTC
Drugs
FDA’s National Center for Toxicological Research (NCTR) has announced the publication of three International Test Method Standards in Nanotechnology by the American Society for Testing and Materials International. The NCTR Nanocore team conducted research that supported consensus standards-development for liposomes, the agency says. The standards are intended to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0800). The revision addresses outsourcing facility registrations and the need to submit certain reports and updates to
Drugs
Sens. Dick Durbin (D-IL), chair of the Senate Judiciary Committee, ranking member Chuck Grassley (R-IA) and Thom Tillis (R-NC) 6/17 introduced bipartisan legislation that would establish a task force between the U.S. Patent and Trademark Office (USPTO) and FDA to improve communication and coordination in
Devices
CDRH has released a draft guidance entitled “Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures.” The document provides recommendations that may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems. Tissue containment
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Guidance on Reagents for Detection of Specific Novel Influenza A Viruses — 21 CFR Part 866” OMB Control Number 0910-0584). The document provides recommendations on measures to help provide a reasonable assurance of safety and effectiveness for
Devices
Some 30 Republican members of the House have written to President Joe Biden asking him to work to alleviate a shortage of intravenous contrast fluids in hospitals. A statement (includes the text of the letter) from Rep. Dan Newhouse (R-WA), one of those signing the 6/14 letter, says
Drugs
FDA has updated its list of off-patent, off-exclusivity drugs without an approved generic. The list, which is updated every six months, includes approved NDAs for drug products that are not protected by patents or exclusivities at the time of each update and for which the agency has not
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” The document describes a standards recognition program for regenerative medicine therapies at CBER to identify voluntary consensus standards to help with the development and assessment of such products. To view
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988” (OMB Control Number 0910-0607). The revision pertains to the inclusion of provisions associated with certificates of waiver. In 2020, FDA revised the guidance document entitled “Recommendations for
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions.” The document provides recommendations for manufacturers about the information that should be included in premarket submissions for radiological devices that include quantitative imaging functions. To view the notice,
Drugs
FDA has released the FDA-483 issued following a 2/14-2/25 inspection at Central Admixture Pharmacy Services, a Phoenix, AZ, outsourcing facility. The six inspection observations were: * procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic
Drugs
FDA has accepted for review a Merck supplemental BLA seeking approval for Keytruda (pembrolizumab) for the adjuvant treatment of patients with Stage IB, II or IIIA non-small cell lung cancer following complete surgical resection. The submission is based on data from the pivotal Phase 3 KEYNOTE-091 trial. Merck
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes the recommendations in an FDA draft guidance on considerations for developing chimeric antigen receptor (CAR) T cell products “are essential in helping sponsors navigate development issues in this rapidly evolving field.” In a 6/14 comment letter, PhRMA says that
Biologics
Lonza Biologics says it appreciates FDA’s efforts to make available the agency’s current thinking on a range of topics applicable to the development of cell and gene therapy products. “Lonza particularly appreciates information specific to chemistry, manufacturing, and controls (CMC) expectations,” the letter says. The company includes detailed
Drugs
CDER researchers say their landscape analysis of the application of artificial intelligence (AI) and machine learning (ML) in drug regulatory submissions from 2016 to 2021 confirms an earlier prediction that AI/ML would play an increasingly important role in drug development. Writing in Clinical Pharmacology & Therapeutics, the authors say
Drugs
Despite all the challenges the Covid-19 pandemic has thrown at FDA, the agency’s drug Center has still been able to meet its user fee goal dates, and all domestic NDA pre-approval inspections that had been earlier delayed due to the pandemic have now been completed, CDER director
Drugs
FDA has approved a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) injection, indicated for chronic weight management in adult and pediatric patients six years of age and older with obesity due to Bardet-Biedl Syndrome (BBS). The therapy was originally approved 11/2020 for chronic weight management in adult and
Drugs
CDER director Patrizia Cavazzoni says the work of the generic drug program during the Covid-19 pandemic is a prime example of how well CDER operated in difficult circumstances. In a memo to staff, Cavazzoni says, “Through cross-office collaboration, the program has been using new approaches during the pandemic
Drugs
Members of FDA’s Psychopharmacologic Drugs Advisory Committee will meet on 6/17 to consider Acadia Pharmaceutical’s resubmitted sNDA for Nuplazid (pimavanserin) for an indication to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. The agency issued a briefing document in advance of the meeting indicating committee