Drugs
Congressman Mike Waltz (R-FL) has written FDA Commissioner Robert Califf asking for clarification on the agency’s “telework policies… which have minimized the operational standards for approving critical drugs and therapeutics.” Waltz noted in his 2/1 letter that it has been four years since the beginning of the
Drugs
FDA has granted Tyra Biosciences a rare pediatric disease designation for TYRA-300, an oral FGFR3 selective inhibitor for treating achondroplasia, the most common form of dwarfism. “A specific DNA mutation in FGFR3 causes an estimated 99% of achondroplasia,” the company says. Tyra is planning to submit an IND in
Devices
Cardinal Health is recalling all sizes of its Monoject sterile Syringe Luer-Lock Tip Soft Packs (1, 3, 6, 12, 20, 35, and 60 mL) and Monoject sterile Enteral Syringes with ENFit connection (1, 3, 6, 12, 35, and 60 mL), which are color-coded purple to denote enteral feeding
Drugs
A new commentary in the 2/2 online Springer Link by CDER Office of Medical Policy officials Ryan Robinson and Leonard Sacks outlines the advantages and challenges of conducting decentralized clinical trials (DCTs). FDA defines DCTs as “trials where some or all of the trial-related activities occur at locations
FDA Policy/General
Federal Register notice: FDA is announcing a 3/15 Oncologic Drugs Advisory Committee meeting. Panel members in the morning are scheduled to discuss a Janssen Biotech supplemental BLA for Carvykti (ciltacabtagene autoleucel) and its use in treating adult patients with relapsed or refractory multiple myeloma and who have received at
Drugs
Seven former FDA commissioners (acting and confirmed) have filed an amicus brief with the Supreme Court urging that a lower court ruling restricting access to the abortion drug mifepristone be reversed. The brief in the closely watched case argues that the Fifth Circuit Court of Appeals should not have substituted
Drugs
FDA has released the forms FDA-483 issued following inspections at four drug manufacturers in three countries. The specific inspection observations for each manufacturer were: * Alvotech Hf, Reykjavik, Iceland — * inadequate environmental/personnel monitoring for a redacted building filling line; * AGC Biologics, Bothell, WA — * written records of investigations into unexplained discrepancies,
FDA Policy/General
FDA Commissioner Robert Califf says artificial intelligence (AI) embedded in clinical decision support or the integration of AI into clinical practice is at a really interesting phase, and it is going to “grow like wildfire,” requiring the agency to hire “three or four times as many people to take on
FDA Policy/General
The Center for Veterinary Medicine has published two data element guidances. The first guidance, Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine, is to help applicants and non-applicants to complete form FDA-1932, “Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect
Drugs
FDA has cleared a NeuroBo Pharmaceuticals IND for a Phase 1 trial of DA-1726, a novel, dual oxyntomodulin analog agonist that functions as a glucagon-like peptide 1 receptor and glucagon receptor as a treatment for obesity. The company says it plans to start the trial in the first
Drugs
Former FDA deputy commissioner Deborah M. Autor has joined consulting group Healthcare Innovation Catalysts (HIC) as chief executive officer. HIC provides advice to clients on regulatory affairs, clinical issues, compliance, federal partnership, and other strategic services. Autor left FDA in 2013 after serving 11 years to join Mylan as senior
Biologics
FDA has accepted for priority review an Adaptimmune Therapeutics BLA for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma. The agency has assigned an 8/4 user fee review action target date. The submission is based on data from cohort 1 of the company’s pivotal
Devices
JDRF (formerly the Juvenile Diabetes Research Foundation) says it applauds FDA for providing important and needed clarity on the agency’s views on the topic of digital health technologies (DHTs) for detecting prediabetes and undiagnosed Type 2 diabetes. Responding to the agency’s request for comment on the topic, JDRF
Devices
FDA has cleared a GE HealthCare 510(k) for its Novii+ Wireless Patch, an antepartum and intrapartum maternal and fetal monitor that measures and displays in real time fetal heart rate, maternal heart rate and uterine activity. “Novii+ allows moms to move around and stay active during labor while providing
FDA Policy/General
Federal Register notice: FDA is issuing a final rule to amend the medical device GMP requirements of the Quality System regulation to harmonize and modernize the regulation with international consensus standards. The rule is effective 2/2/2026. To view the notice, click here.
Drugs
As part of its review of an Abeona Therapeutics BLA for pz-cel (prademagene zamikeracel) for recessive dystrophic epidermolysis bullosa, FDA has completed a bioresearch monitoring inspection of Abeona and the BLA mid-cycle review meeting. A company statement says the 1/22-1/24 inspection did not result in
Devices
FDA has published a final rule, Quality Management System Regulation Final Rule, to amend the current Quality System Regulation good manufacturing practice (CGMP) requirements to harmonize with an international standard. The document will take effect on 2/2/26, giving medical device manufacturers and importers two years to modify their
Drugs
FDA has released a Revised Biosimilar User Fee Amendment (BsUFA) Research Roadmap that provides updated information about the biosimilar regulatory science research pilot program’s research priorities. The revised roadmap says the draft that was issued in 1/2023 was updated from public docket comments and a 10/2023 public
Drugs
The House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations will hold a 2/6 public hearing on “Protecting American Health Security: Oversight of Shortcomings in FDA’s Foreign Inspection Program.” In a statement, committee chair Rep. Cathy Morris Rodgers (R-WA) and subcommittee chair Morgan Griffith (R-
Biologics
Biogen says it is discontinuing the further development and commercialization of controversial Alzheimer’s drug Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use as part of a move to reprioritize its resources in the disease space. Aduhelm’s 2021 approval was met with public concern and outrage, much
Biologics
CBER has posted its “guidance agenda” for 2024 that includes a listing of topics upcoming guidances will address. The agenda includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued earlier draft guidances that may
Drugs
FDA has issued a warning on South Moon and Rebright or FivFivGo eye drops because of potential risks for eye infections. “These are copycat eye drop products that consumers can easily mistake for Bausch + Lomb’s Lumify brand eye drops, an over-the-counter product approved for redness relief,” the