Drugs
A 10/20-10/30/2025 FDA inspection at SCA Pharmaceuticals’ outsourcing facility in Little Rock, AR, found serious deficiencies in the firm’s practices for producing drug products that are intended or expected to be sterile. A just-released 9/14 Warning Letter says the agency investigator collected evidence
Drugs
Vanda Pharmaceuticals says its development program for VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor partial agonist, is on hold after the therapy failed to meet its primary endpoint in a Phase 3 clinical study in patients with social anxiety. The study, VP-VQW-765-3201 (Study
Drugs
The Antidepressant Coalition for Education is petitioning FDA to require postmarketing studies and a national patient registry for selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI). The petition says the patient registry should prospectively follow patients during and after SSRI or SNRI tapering or discontinuation and should
FDA Policy/General
Drugs
FDA has accepted for review an Aquestive Therapeutics NDA resubmission for Anaphylm (dibutepinephrine) sublingual film for treating Type I allergic reactions, including anaphylaxis. The agency has set a review action target date of 3/16/2027. In January, FDA issued the company a complete response letter (CRL) on the original
FDA Policy/General
Former Sheppard, Mullin life sciences and FDA practice attorneys Scott Liebman and Dominick DiSabatino have joined Mayer Brown as partners in its Life Sciences practice. “They specialize in FDA rules and regulations and further strengthen Mayer Brown's capabilities advising pharmaceutical, biotechnology, medical device, healthcare, and digital health companies
FDA Policy/General
Three former FDA commissioners sharply criticized the Trump administration’s staff cuts at FDA over the last year, warning that the loss of experienced scientific and regulatory staff has weakened the agency's institutional knowledge and will take years to reverse. Speaking 10/14 at the 2026 STAT Summit
FDA has asked NRx Pharmaceuticals to submit “minor” changes to the submitted label for the company’s preservative-free ketamine product NRX-100. A company statement says NRx was asked to submit sample labeling with the proposed proprietary name currently under review in advance of the 11/10 GDUFA target
FDA Policy/General
The Milken Institute is urging the FDA and other federal agencies to overhaul clinical trial policies, arguing that unnecessarily restrictive eligibility criteria, cumbersome consent requirements and fragmented regulatory oversight are limiting patient participation and slowing medical research. In a 10/13 report, Enabling Access to Clinical Research: An Action Plan
FDA Policy/General
The growing use of online prediction markets Kalshi and Polymarket to wager on clinical trial outcomes and FDA drug approvals could compromise trial integrity, encourage insider trading, and undermine public confidence in regulatory decisions, three Boston University researchers warned. Kalshi launched a pilot program in July (see earlier story) allowing
Independent news and analysis of FDA regulation, policy and enforcement
Two federal employee unions have accused FDA of violating employees’ First Amendment rights by prohibiting off-duty union activities and restricting the use of agency computers and networks for union-related communications. In a 10/9 letter to FDA acting commissioner Kyle Diamantas and chief operating officer Melanie Keller, the
FDA says it is launching a Rare Disease Framework Initiative “to reimagine the development of drugs and biologics for rare diseases.” In a statement, which includes a link to a new white paper on the initiative, the program will “develop an optimized, fit-for-purpose framework that reflects the realities
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA’s attention to container closure systems in light of the significant technological advances that have emerged in material science and drug delivery systems since the agency’s 1999 guidance on the same topic. In a comment letter on an
Former FDA commissioner Scott Gottlieb is calling on Congress to establish a new regulatory pathway for clinical artificial intelligence models developed and used within hospitals, warning that the absence of consistent federal oversight could undermine patient safety and limit broader commercialization of clinical AI technologies. In an October 8 commentary
A 4/7-4/18/2025 FDA Bioresearch Monitoring Program inspection at Lovelace Biomedical Research Institute in Albuquerque, NM, found objectionable conditions in the facility’s role in conducting two nonclinical laboratory studies. A 10/6 Warning Letter says the specific violation was: * failure of the quality assurance unit to
A 3/26-4/2 FDA inspection of the Silgan Unicep Packaging drug manufacturing facility in Spokane, WA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/5 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy or failure
Ultragenyx Pharmaceutical says it has entered into an agreement to sell to an undisclosed buyer a Rare Pediatric Disease Priority Review Voucher (PRV) for $203 million. Ultragenyx won the PRV upon FDA approval of Fayuvi (rebisufligene etisparvovec-hopf), also known as UX111, the first-ever FDA-approved treatment for mucopolysaccharidosis
FDA has accepted for review a Pierre Fabre Pharmaceuticals BLA resubmission with a proposed indication as monotherapy for treating adult and pediatric patients 2 years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. The agency
FDA has approved Altor BioScience’s Anktiva (nogapendekin alfa inbakicept-pmln) with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The approval revises the prior indication for adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors to
An analysis by two University of Southern California policy researchers finds that between 2013 and 2022, some 38% of FDA advisory committees included either a patient or consumer representative with active ties to an advocacy organization funded by a drug company. Writing in an open-source article for Project Hope,
Former FDA regulatory counsel and now-partner at Spencer Fane Brian Malkin is questioning whether the agency should become more directly involved in the Trump administration's drug-pricing initiatives, raising concerns about the potential direction of FDA policy under commissioner nominee Heidi Overton, whose nomination remains pending in
FDA researchers and academic collaborators identified nearly 80,000 prescription opioid-related cardiovascular adverse event signals in a large-scale analysis of the agency's Adverse Event Reporting System, suggesting that machine learning could improve postmarketing drug safety surveillance. The study, published September 28 in Frontiers in Drug Safety