Drugs
A 11/12-11/21/2025 FDA inspection at the Huons Co. drug manufacturing facility in Jecheon, Chungcheongbuk, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/15 Warning Letter says the four specific violations were: * failure to ensure that laboratory records
FDA Policy/General
A Skadden Insights post says the departure of former FDA commissioner Marty Makary and several of his senior executives has led to regulatory uncertainty in regulated companies. “Many of the initiatives that defined the Makary era were never enshrined in formal rules or guidance, but rather were announced by press
Devices
FDA has issued an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used with Impella heart pump systems manufactured by Abiomed and its manufacturing partner Oscor. According to the agency, certain 14 French and 23 French introducer sheaths may develop unexpected leakage from
Drugs
FDA says it purchased three unapproved new drugs from the Amazon Web site and directed the company to address the violations promptly and ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence. A 6/17 Warning Letter says two of the products were indicated
FDA Policy/General
Former FDA commissioner Scott Gottlieb is praising the agency's newly announced initiative to accelerate early-stage clinical trials, arguing that the package of reforms could help reverse the migration of Phase 1 studies to overseas markets such as China and Australia. Speaking on CNBC’s Squawk Box, Gottlieb
FDA Policy/General
HHS has launched a broad, department-wide initiative (Operation TrialBlazer) aimed at speeding clinical research, reducing regulatory barriers, and attracting more clinical trials back to the U.S. A centerpiece of the initiative is a new FDA proposal to establish a pilot program designed to shorten the timeline between drug
Drugs
FDA has released a draft guidance outlining how sponsors can use quantitative systems pharmacology (QSP) models to determine starting doses for first-in-human (FIH) clinical trials, particularly for higher-risk therapies where traditional animal-based approaches may be less predictive. The document focuses on using QSP models to estimate
Drugs
FDA has issued a revised draft guidance that updates how sponsors can demonstrate "substantial evidence" of effectiveness for new drugs and biologics, reflecting advances in clinical trial design, real-world evidence, and precision medicine. The document is part of an HHS and FDA initiative (see story) to help
Drugs
FDA has released a revised draft guidance aimed at helping sponsors design and conduct clinical trials using master protocols, a trial framework increasingly used to evaluate multiple therapies, diseases, or patient populations within a single overarching study. The draft guidance, Master Protocols for Drug and Biological Product Development, replaces a
Drugs
Regenxbio has reached agreement with FDA on a path toward a potential accelerated approval of Navsunli (clemidsogene lanparvovec-sngl), the first gene therapy for treating Hunter syndrome, or mucopolysaccharidosis type II (MPS II). The company says FDA has concluded that existing clinical data for the gene therapy are sufficient to
Drugs
A new analysis published in the journal Frontiers in Pharmacology found substantial differences in how major international regulators evaluate and approve oncology drugs that first receive expedited approval from FDA, despite often reviewing largely the same clinical evidence. Researchers from Ewha Womans University in South Korea and Keio University in
FDA Policy/General
Former FDA commissioner Scott Gottlieb is urging federal health officials to restore scientific leadership at the agency's medical product centers, arguing that recent political appointments and workforce losses have weakened the agency’s effectiveness and credibility. In a commentary published in JAMA Health Forum, Gottlieb said FDA has
Drugs
Former FDA Office of New Drugs (OND)director Peter Stein sharply criticized the agency's National Priority Voucher (NPV) program at the DIA Global Annual Meeting in Philadelphia last week, arguing that its one- to two-month review timeline undermines the rigor of FDA's drug review process.
Drugs
An opinion article is calling on FDA acting commissioner Kyle Diamantas to establish a formal regulatory framework for evaluating vaccines as potential interventions to prevent dementia, arguing that the absence of clear guidance is hindering the launch of large-scale clinical trials. In an open letter published by Clinical Trial
Drugs
Merck says FDA has approved an expanded indication for its pneumococcal conjugate vaccine, Capvaxive, allowing its use in children and adolescents aged 2 to 17 years who have completed a primary pneumococcal vaccination series and are at increased risk for pneumococcal disease due to chronic medical conditions. The action makes
Biologics
FDA has given Beam Therapeutics the green light in its IND for BEAM-304, allowing the company to begin clinical testing of its experimental base-editing treatment for phenylketonuria (PKU). The clearance enables the launch of a Phase 1/2 trial evaluating BEAM-304, an in vivo gene-editing therapy
Drugs
FDA has approved the first generic version of Genentech’s Xofluza (baloxavir marboxil), clearing Norwich Pharmaceuticals' generic tablets for the treatment and prevention of influenza in patients aged five years and older. The approval covers the drug’s administration as a single oral dose for acute uncomplicated influenza. The
Biologics
The FDA Vaccines and Related Biologic Products Advisory Committee has voted to recommend approval of Moderna’s mFlusiva mRNA flu shot. The Associated Press reports the company is seeking approval for the vaccine’s use in people ages 50-64, along with authorization for use in those aged 65 and
Drugs
FDA is requesting updates to the prescribing information for testosterone replacement therapy products following what it calls a comprehensive review of clinical data and existing scientific evidence. A HHS news release says the labeling changes would: * remove the limitation of use that says the safety and effectiveness of testosterone replacement
Drugs
FDA has released an unusual internal memorandum detailing how former CDER acting director Tracy Beth Hoeg opposed approval of a Sanofi supplemental BLA for Tzield, only to have her position overturned after her departure from the agency. The sBLA was eventually approved earlier this month The just-posted memo from
Drugs
Grace Therapeutics says it plans to resubmit its NDA for GTx-104 after receiving an FDA Complete Response Letter in April, with a Type A meeting now scheduled to clarify the agency's expectations and outline a path forward for the intravenous nimodipine candidate. The letter cited outstanding manufacturing
Devices
FDA has provided additional details on its newly launched READI-Home Innovation Challenge, an initiative designed to accelerate development of medical devices intended to reduce avoidable hospital readmissions by supporting patients in home settings following discharge. The challenge, formally known as READI-Home: Reducing Readmissions through Device Innovation for the