Biologics
Pfizer and BioNTech have submitted a supplemental BLA that seeks approval of their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for use as a primary series and booster dose for individuals 12 years of age and older. The submission adheres to last month’s Vaccines and Related
FDA Policy/General
A Pfizer NDA to convert its emergency use authorization for Covid-19 drug Paxlovid (nirmatrelvir and ritonavir co-packaged tablets) to a traditional approval is heading to a 3/16 Antimicrobial Drugs Advisory Committee meeting review and vote. The company is seeking an indication for treating mild-to-moderate coronavirus
Drugs
FDA has released a draft guidance entitled “Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment.” The document provides recommendations to sponsors regarding eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and improve efficiencies in drug development programs. The guidance recommends a parallel-group,
EIRs/483s
FDA commissioner Robert Califf continues to call for better evidence generation and suggests that with the rapidly advancing artificial intelligence (AI) space (e.g., ChatGPT and other competitors) it is just a matter of time before the agency receives its first “AI-assisted” marketing submission. “As we develop much better
Drugs
A letter from six House Democrats urges FDA to do more to help resolve the ongoing shortage of pediatric ibuprofen and acetaminophen. Over the past six months, an increase in demand has been attributed to recent surges in Covid-19, respiratory syncytial virus and influenza, any of which can cause
Drugs
CDER has named Office of Compliance deputy director Jill Furman as permanent director after serving as acting director since previous head Don Ashley retired in November. Furman joined CDER in 2020 and has provided “strategic direction for risk-based decision-making in a broad range of critical areas, such as
Devices
FDA has issued Lucira an emergency use authorization for the first over-the-counter (OTC) at-home diagnostic test for detecting influenza A and B, and Covid-19. The single-use test uses nasal swab samples and provides results in about 30 minutes. Those being tested should report positive results
Devices
An FDA 12/9/22 draft guidance, Content of Human Factors Information in Medical Device Marketing Submissions, “seems like mission creep” for FDA to go beyond the stated primary purpose to impose a dramatic expansion of the requirement. That’s the view of attorney Jeffrey Shapiro (Hyman, Phelps & McNamara)
Drugs
Octapharma USA has submitted an sBLA to FDA to expand the approval of Wilate (von Willebrand factor/coagulation factor VIII complex [human] lyophilized powder for solution for intravenous injection) to reduce the frequency of bleeding episodes in children and adults with any type of von Willebrand disease (VWD). The company
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it is generally supportive of the International Council for Harmonization/FDA M11 Clinical Electronic Structured Harmonized Protocol with the M11 template and technical specification. The association's comment letter says it believes the documents provide “important standards for the content, format,
Drugs
The Centers for Medicare & Medicaid Services (CMS) says it is not reconsidering its national coverage determination (NCD) that restricts Medicare coverage on Alzheimer’s monoclonal antibodies approved under FDA’s accelerated approval pathway. CMS reiterated its position in response to an Alzheimer’s Association request for reconsideration. Currently, FDA
Drugs
University of Pennsylvania Perelman School of Medicines and Flatiron Health researchers say that given an increasing withdrawal of accelerated approval (AA) cancer drugs due to negative confirmatory trials and emerging evidence on the high spending associated with AA drugs, it is “critical to balance early access against population-level exposure
Biologics
FDA has approved a Bioverativ Therapeutics (a Sanofi company) BLA for Altuviiio (efanesoctocog alfa), a recombinant DNA-derived, factor VIII concentrate indicated for use in adults and children with hemophilia A. The drug is approved for routine prophylaxis to reduce bleeding episodes, on-demand treatment and control of bleeding episodes,
Drugs
A new study in JAMA that looked at ivermectin as a therapy for treating adult outpatients with mild to moderate Covid-19 finds that the drug’s use is not supported. The study by researchers from Duke, Vanderbilt, and Johns Hopkins, among numerous other institutions, involved 1,200 patients and
Devices
FDA says it has added a new case study to the Examples of Medical Device Misconnections Web page. An agency notice says the new case study involves an air inflation line from a noninvasive vascular diagnostic system erroneously connected to an intravenous catheter with the same connector as a blood
Devices
FDA has published a “sources sought” information request to survey potential contractors on their expertise and capabilities to develop and implement a medical device active surveillance system involving electronic health record (EHR) data to better understand device safety within clinical practice settings. The agency says the primary need for an
Devices
FDA says it is evaluating published literature that reports elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals from neonatal incubators. An agency letter to healthcare providers says the potential sources of the airborne chemicals include materials used to make the incubators as well as natural and human-made sources
Drugs
Sens. Elizabeth Warren (D-MA) and Bernie Sanders (I-VT) and Reps. Pramila Jayapal (D-WA) and Katie Porter (D-CA) are calling on the U.S. Patent and Trademark Office (USPTO) to closely scrutinize any Merck requests for new patents for its cancer treatment Keytruda (pembrolizumab). A statement (includes
Drugs
FDA has released the form FDA-483 issued following a 12/13-12/21/22 inspection at Amneal Pharmaceuticals Private Limited, an Ahmedabad, Gujarat, India pharmaceutical parenteral manufacturer. The nine-page document lists 16 narrative observations of objectionable conditions made by the agency investigator.
Biologics
CBER director Peter Marks says principles implemented during the Covid-19 pandemic may have implications for the future development of vaccines and possibly other medical products, “ushering in the start of a new era in regulation.” Writing in Expert Review of Vaccines, Marks says that in setting out to rapidly
FDA Policy/General
Federal Register notice: FDA has determined that Allergan’s Asacol HD (mesalamine) delayed-release tablet, 800 mg, was not withdrawn due to safety or effectiveness reasons. The determination means that FDA will approve ANDAs as long as they meet relevant legal and regulatory requirements. Asacol HD is indicated for treating
FDA Policy/General
Federal Register notice: FDA has determined that Janssen’s Topamax (topiramate) sprinkle capsules, 50 mg, was not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs for topiramate sprinkle capsules if all other legal and regulatory requirements are met. Topamax is indicated for treating