Devices
FDA has released new guidance detailing how manufacturers should design and submit regulatory applications for patient-matched guides used in orthopedic implant procedures, as the agency seeks to standardize a rapidly evolving category of medical devices. The document, titled “Patient-Matched Guides for Orthopedic Implants,” reflects FDA’s current thinking
Drugs
Some 30 bipartisan members of the House of Representatives are calling on FDA to advance its evaluation of rapid-acting novel therapeutics, including entactogen and psychedelic-assisted therapies, to treat serious mental health conditions. In a letter organized by Reps. Jack Bergman (R-MI) and Lou Correa (D-CA) the
FDA Policy/General
FDA has launched a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model and deploy inspection resources more efficiently. The initiative is intended to introduce shorter, targeted facility reviews designed to complement, rather than replace, the agency’s traditional, multi-day
Drugs
FDA commissioner Marty Makary says the agency is undertaking a major hiring push and a series of operational reforms aimed at strengthening its scientific workforce, modernizing inspections and reversing what he described as a loss of U.S. leadership in early-stage drug development. Speaking at the Food and Drug
Drugs
FDA has released the form FDA-483 issued following a 1/7-1/17/2025 inspection at the Bio-Thera Solutions drug substance and drug product manufacturing facility in Guangzhou, Guangdong Province, China. The six inspection observations were: * failure to fully establish or follow procedures designed to prevent microbiological contamination
Drugs
FDA has awarded a Commissioner’s National Priority Voucher to Partner Therapeutics for its Bizengri (zenocutuzumab-sbco) to treat adults with advanced, unresectable, or metastatic cholangiocarcinoma harboring a neuregulin 1 gene fusion with disease progression on or after prior therapy. A company statement says it submitted a BLA to FDA
Drugs
FDA has published a guidance, Chemistry, Manufacturing, and Controls Flexibilities for Developing a Human Cellular and Gene Therapy Product for a Biologics License Application, describing how the agency applies flexibility to the chemistry, manufacturing, and controls (CMC) requirements for human cellular and gene therapy (CGT) products being developed for BLAs.
Drugs
FDA will convene a virtual public meeting later this month to address industry questions tied to a planned pilot program exploring the use of artificial intelligence in early-stage clinical trials. The 5/15 virtual session will focus on an agency request for information seeking stakeholder input on how AI-
Devices
A 9/19-12/4/2025 FDA inspection at the Unetixs Vascular facility in Warwick, RI, determined that the firm is illegally selling adulterated and misbranded vascular diagnostic ultrasound systems, including the ROODRA and 2CP devices. A 4/15 Warning Letter says the devices are adulterated because the firm does
Drugs
FDA is reaffirming support for decentralized clinical trials (DCTs) while making clear that moving trial activities outside traditional research sites does not reduce sponsor accountability, according to new client alert from Crowell & Moring. In updated guidance, the agency signaled that decentralized elements — such as telehealth visits, home-based care,
Drugs
During a CNBC interview at a 5/4 Milken Institute conference, FDA commissioner Marty Makary forcefully defended the agency against mounting criticism of recent drug rejections, arguing the agency is “following the science” while accelerating broader reforms aimed at speeding approvals and restoring U.S. biotech competitiveness. Makary pushed back
Drugs
FDA has issued a Warning Letter to CareFusion, a subsidiary of Becton Dickinson, citing widespread and repeat violations of current good manufacturing practice regulations at a Texas facility that produces sterile drug products. The 4/30 letter follows an FDA inspection at the company’s El Paso manufacturing site conducted
Drugs
An FDA review of records provided by Respilon Production S.R.O., a producer of over-the-counter drugs in Jihomoravsky, Czechia, in response to the agency’s 5 /2/2025 request, found five significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/20 Warning
Drugs
FDA’s accelerated approval pathway, which is more than three decades old, has undergone major changes since 2024 following mounting evidence of systemic weaknesses, including delayed confirmatory trials, questionable validity of surrogate endpoints, and inconsistent enforcement. A Bioprocess Online guest column says the changes started with a 2024 comprehensive draft
Drugs
FDA and TransCelerate are reporting highlights from a recent joint tabletop exercise in which the CDER Center for Clinical Trial Innovation and the nonprofit focused on how to streamline the collection of safety data, which TransCelerate says is an essential step in scaling the use of pragmatic elements in clinical
Drugs
FDA has withdrawn or blocked the publication of multiple internal studies supporting the safety of Covid-19 and shingles vaccines, according to a report by CNBC, a move that is drawing scrutiny in light of the agency’s stated commitment to “radical transparency.” A spokesperson for the U.S. Department
Drugs
A 10/27-10/31/2025 FDA inspection at the Active Cosmetics Manufacturing drug manufacturing facility in Orlando, FL, found three significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/22 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy
Drugs
FDA has issued an untitled letter to Bayer HealthCare Pharmaceuticals, citing misleading direct-to-consumer advertising for its prostate cancer drug Nubeqa. In the letter, FDA’s Office of Prescription Drug Promotion said a YouTube video and a Spanish-language television advertisement for Nubeqa omit key safety information and fail
Drugs
FDA commissioner Marty Makary is signaling a broad push to overhaul how the agency reviews new drugs, aiming to reduce early-stage regulatory friction, accelerate clinical trials, and expand the use of novel programs designed to shorten approval timelines. In remarks at a 5/4 Milken Institute conference detailing his
FDA Policy/General
FDA is facing mounting internal strain and external criticism just over a year into commissioner Marty Makary’s tenure, according to accounts from agency staff, industry executives and policymakers, raising questions about leadership stability at the nation’s top drug regulator. Makary, initially viewed as a conventional and well-qualified
Drugs
Clene says it plans to submit an NDA in the third quarter for its experimental amyotrophic lateral sclerosis (ALS) therapy, CNM-Au8, following feedback from FDA that indicated the company’s data could support an accelerated approval. According to the company, FDA officials indicated during a recent Type C meeting
Drugs
The U.S. Supreme Court has temporarily blocked a 5/1 lower court ruling that would have curtailed access to the abortion pill mifepristone, preserving the current FDA regulatory framework while the justices consider emergency appeals. The administrative stay, issued by justice Samuel Alito, halts the U.S. Court of