Drugs
In responding to an FDA Request for Information (RFI) on an AI-enabled optimization of early-phase clinical trials pilot program, the Association of Clinical Research Organizations (ACRO) makes these points: * contract research organizations are a keystone in building the architecture for real-time, continuous clinical trials; * the RFI is
FDA Policy/General
The Trump Administration is considering White House health policy adviser Heidi Overton as a leading candidate to become the next FDA commissioner, according to Bloomberg reporting that cited people familiar with the selection process. No final decision has been made, and administration officials continue to evaluate candidates for the position.
Biologics
A Covid-19 vaccine effectiveness study that was previously blocked from publication in a Centers for Disease Control and Prevention (CDC) journal has now been published in JAMA Network Open, reigniting a debate over both vaccine policy and the methods used to evaluate vaccine performance. The study found that the
FDA Policy/General
In the first of three planned online posts on FDA’s FY 2027 Appropriations Report, approved by the House Appropriations Committee to explain its agency funding bill, eight Hyman, Phelps & McNamara lawyers say the report “reflects a Congress eager to shape FDA’s regulatory priorities — from promoting artificial intelligence
Drugs
The Federal Trade Commission (FTC) has filed an amicus brief supporting plaintiffs in an antitrust lawsuit accusing Johnson & Johnson of unlawfully maintaining a monopoly over its blockbuster autoimmune drug Stelara through anticompetitive conduct. The case was brought by CareFirst of Maryland, which alleges that J&J preserved its
Drugs
A new CDER Office of New Drugs (OND) webinar discusses the development and use of OND Custom Medical Queries (OCMQs) to identify potential safety signals during review of clinical trial adverse event data in new molecular entity NDAs/BLAs and related supplements. During the webinar, Biomedical Informatics and Regulatory Review
Devices
Harmed Americans for Reform in Medical Device Safety, which is led by cardiac surgeon Nooman Noorchashm, known to FDA for his opposition to power morcellation and for raising issues about surgical mesh, is petitioning the agency to require Vena Medical to obtain an IDE for its MicroAngioscope. The 6/22
FDA Policy/General
FDA acting chief of staff and deputy commissioner Lowell Zeta says the agency has secured 600 new employees and is looking to bring in another 1,600 as it works to recover from the massive staff cuts orchestrated in 2025 by the so-called Department of Government Efficiency. As reported
Drugs
A new analysis published in JAMA Psychiatry is raising fresh questions about how FDA evaluates drug efficacy when clinical trial results are mixed, using the decades-long regulatory journey of the antidepressant Exxua (gepirone) extended release as a case study. In a Special Communication published 6/24, researchers examined the
EIRs/483s
FDA has granted Pfizer expanded approval for Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with hormone receptor (HR)-positive, HER2-positive locally advanced or metastatic breast cancer following induction therapy. The 6/24 approval expands the use of the
Drugs
FDA has published the CDER 2025 Drug Trials Snapshot Summary Report with summarized baseline demographic information from pivotal trials that supported the approval of 46 novel drugs in 2025. The report says that 20 (43%) of the approved novel drugs were first-in-class, while 23 (50%) were indicated to
Drugs
FDA has issued Achieve Life Sciences a Complete Response Letter (CRL) on its NDA for cytisinicline as a treatment for nicotine dependence. “The CRL relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility and to final product labeling that
Drugs
FDA has released the form FDA-483 issued following a 3/30-4/8 inspection at Pharmaneek, an Indianapolis, IN, producer of non-sterile drug products. The form FDA-483 says the specific inspection observations were: * production of hazardous drugs without providing adequate containment, segregation, and/or cleaning of work
Devices
FDA has formally closed an enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about whether the company's Blood Pressure Insights feature should be regulated as a medical device. In a recently issued closeout letter, FDA informed the wearable technology company that it had
Drugs
Real-world evidence (RWE) generated from real-world data (RWD) remains underutilized in drug approvals. That’s the report from several drug company officials, including one former FDAer, writing in Therapeutic Innovation & Regulatory Science. The authors note that beyond the fundamental need for relevant and reliable RWD, three interdependent
Drugs
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Drugs
A 10/20-11/3/2025 FDA inspection at the Jubilant HollisterStier General Partnership drug manufacturing facility in Kirkland, Quebec, Canada, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 5/28 Warning Letter says the specific violations were: * failure to establish and
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