Drugs
The Association for Accessible Medicines (AAM) says it appreciates FDA efforts to promptly revise a 2020 guidance to implement new commitments regarding controlled correspondence in the commitment letter authorizing GDUFA renewal. The association’s letter says the revised draft guidance “continues to provide useful information about what FDA will and
Devices
FDA has published three guidances relating to x-ray systems. The first, Performance Standards for Diagnostic X-Ray Systems and Their Major Components; Small Entity Compliance Guide, is intended to assist small entities to comply with a 2005 final rule amending the performance standard for diagnostic x-ray systems and
Drugs
FDA has accepted for priority review a Pfizer BLA for elranatamab to treat patients with relapsed or refractory multiple myeloma. The company says FDA is expected to decide on the BLA this year. Elranatamab is described as an investigational off-the-shelf, humanized BCMA CD3-targeted BsAB. BsABs are described
Drugs
FDA has expanded its warning against using specific artificial tears products to now include Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination. The over-the-counter product is also manufactured by Tamilnadu, India’s Global Pharma Healthcare, which was issued an import alert and a safety warning
Devices
FDA has cleared a RapidAI 510(k) for Rapid RV/LV, a tool for physicians to quickly assess the ratio between the right ventricle (RV) and the left ventricle (LV), a key indicator of pulmonary embolism (PE) severity. “Automating this process will enable care teams to more quickly prioritize patients
Devices
The U.S. Supreme Court has declined to hear a Johnson & Johnson case that sought the high court’s review and reversal of a California Court of Appeal decision imposing $300 million in civil penalties on the company’s Ethicon unit for marketing its pelvic mesh product in the
Drugs
FDA has accepted for priority review a Regeneron BLA for pozelimab (C5 antibody) to treat children and adults with CHAPLE disease. A company statement says CHAPLE is an ultra-rare disease also known as CD55 deficiency with Hyperactivation of complement, Angiopathic thrombosis and Protein Losing Enteropathy or CD55-deficient protein-
Drugs
FDA has notified Akebia Therapeutics that due to agency resource constraints and staffing needs, the deciding authority for the company’s formal dispute resolution request about the complete response letter received on 3/2022 for its vadadustat will be CDER Office of New Drugs (OND) director Peter Stein. The company
Drugs
FDA has extended to 5/22 the PDUFA priority review action date for Astellas Pharma’s fezolinetant, an investigational drug to treat moderate to severe vasomotor symptoms due to menopause. The company says the agency said it needed more time to complete its review of the Astellas NDA.
FDA Policy/General
FDA commissioner Robert Califf says anyone who thinks government alone can solve the misinformation problem “is deluding themselves. We need a vast network of knowledgeable people who devote part of their day to combating misinformation,” he said in an interview with the Associated Press (AP). Communications experts contacted by AP
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Biologics License Applications (BLAs) Procedures and Requirements.” The collection supports agency regulations and recommendations found in associated guidance documents on BLA procedures and requirements. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is revising an information collection entitled “Premarket Notification — 21 CFR Part 807, Subpart E” to add the estimated burden for a certification that accompanies 510(k) submissions. To view the notice, click here.
Devices
FDA has published guidances relating to marketing clearances of diagnostic ultrasounds and 510(k) submissions for ultrasonic diathermy devices. The first guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, gives detailed recommendations for 510(k) submissions for diagnostic ultrasound systems and transducers. FDA says that in addition to outlining
Drugs
Intarcia Therapeutics has accepted a proposal (see earlier story) from FDA chief scientist Namandjé N. Bumpus to allow an advisory committee to review and address a 2021 CDER decision not to approve the company’s NDA for ITCA 650 (exenatide in DUROS device), a drug/device combination product intended to
FDA Policy/General
Merck says a study of its Covid-19 drug Lagevrio (molnupiravir) did not demonstrate a statistically significant reduction in the risk of Covid-19 in those who were exposed to the virus by another in their household. In the company’s Phase 3 MOVe-AHEAD trial, the Lagevrio-treated group
Drugs
HHS has published its semiannual regulatory agenda that outlines numerous FDA rulemaking activities under development, such as a final rule entitled “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format” and proposed rules entitled “Medication
Biologics
Pfizer has informed FDA it has decided to drop a significant percentage (about 50%) of U.S. participants enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) Phase 3 study. A company statement says the participants are being dropped following violations of good clinical practice requirements at certain clinical
Drugs
FDA has granted priority review for a Merck sNDA for its Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk. A company statement says the PDUFA action date on the sNDA is 6/5. FDA also accepted for review a second sNDA to
Drugs
FDA has accepted an Iveric Bio NDA for avacincaptad pegol, described as a novel investigational complement CS inhibitor for treating geographic atrophy secondary to age-related macular degeneration. The company says the PDUFA action date on the NDA is 8/19. The agency granted priority review of the NDA. Iveric
FDA Policy/General
Federal Register notice: FDA is providing an opportunity to submit written comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions on three drug substances. Comments received will be considered in preparing the U.S. position on these proposals at a United Nations meeting. The
Drugs
Eisai CEO Ivan Cheung says the company expects FDA to fully approve its Alzheimer’s drug Leqembi (lecanemab) this summer. In a 2/16 interview with CNBC, Cheung said approval could come as soon as July if the agency gives Leqembi priority review for demonstrating a significant improvement in how
Drugs
FDA has approved Chiesi Global Rare Diseases’ Lamzede (velmanase alfa-tycv) to treat non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. The company says Lamzede is a recombinant form of human alpha-mannosidase intended to provide or supplement natural alpha-mannosidase, an enzyme that is