Drugs
FDA has published a draft guidance, Monoclonal Antibodies: Streamlined Nonclinical Safety Studies, to assist sponsors in implementing streamlined approaches for nonclinical safety assessments of monoclonal antibodies that recognize a singular molecular target, referred to as monospecific antibodies. The document says it is intended to facilitate drug development for monospecific antibodies
Drugs
A 6/2-6/5 FDA inspection at the Rhyz Analytical Labs contract testing laboratory in Provo, UT, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 11/12 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy
Drugs
A 1/14-1/24 FDA inspection at the Turbare Manufacturing outsourcing facility in Conway, AR, found serious deficiencies in the firm’s practices for producing drug products intended or expected to be sterile. A just-released 9/16 Warning Letter says the agency investigator noted that products intended or
Drugs
FDA has published a guidance, QTc Information in Human Prescription Drug and Biological Product Labeling, to assist applicants in incorporating heart rate-corrected (QTc) interval of prolongation-related information in the labeling of non-antiarrhythmic human prescription drug and biological products. The document provides recommendations to help ensure that clinically
Drugs
A Washington, DC, federal judge has ruled that FDA acted unlawfully when it denied a priority review voucher to Sun Pharma and its drug Sezaby (phenobarbital sodium), the first FDA-approved treatment specifically shown to be effective for neonatal seizures. The decision criticized the agency’s reliance on a long-
Drugs
In an unexpected move, recently appointed CDER director Richard Pazdur has filed paperwork to retire by the end of the month, according to multiple reports citing people familiar with the matter. While the retirement paperwork has been filed, insiders indicate Pazdur could still change his mind and retract the resignation.
Drugs
FDA has issued an early alert concerning certain Abbott Diabetes Care glucose monitor sensors, warning patients and healthcare providers about potentially dangerous inaccuracies in blood sugar readings. The alert covers certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors. Abbott recently notified distributors, healthcare providers, and customers, advising that
Drugs
Hi-Tech Pharmaceuticals CEO and twice-convicted felon Jared Wheat has been found guilty of orchestrating a years-long scheme to forge manufacturing safety certifications and defraud customers out of more than $4.7 million. The Norcross, Ga.–based dietary supplement manufacturer was also convicted on multiple counts, including wire
Drugs
FDA has issued a safety alert after Becton Dickinson (BD) recently recalled (Class 1 device correction) certain Alaris Pump Modules if they have been dropped or severely jarred, citing risks of inaccurate drug delivery that could lead to serious injury or death. The company notified customers 10/17 that the
Drugs
Belite Bio is reporting positive topline results from the global Phase 3 DRAGON trial of tinlarebant, marking what the company says is the first successful pivotal trial in patients with Stargardt disease Type 1 (STGD1). The eye disease leads to progressive vision loss, usually beginning in childhood or young adulthood,
Drugs
FDA says it has deployed advanced “agentic AI” capabilities to all agency employees, marking a major expansion of its artificial intelligence (AI) tools for regulatory and scientific work. According to the agency, Agentic AI systems are designed to plan, reason, and execute multi-step tasks autonomously while incorporating human oversight
Drugs
FDA has accepted for review a MannKind supplemental NDA for its Furoscix ReadyFlow autoinjector, a fast-acting device designed to treat edema in adults with chronic heart failure or chronic kidney disease. The agency has set a user fee review action target date of 7/26/2026. The ReadyFlow autoinjector
Drugs
FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy as a perioperative treatment for adults with resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. The regimen — durvalumab plus fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) — will be used both before and after surgery, followed by single-agent durvalumab for up
Drugs
FDA has extended by three months its review of an Ascendis Pharma NDA for TransCon CNP (navepegritide) and its use for treating children with achondroplasia. The agency told the drugmaker that additional information Ascendis submitted earlier this month, including a revised protocol for a required post-marketing study, constituted a
Drugs
FDA has released the form FDA-483 with nine observations from a 9/8-9/16 inspection at the Fareva Amboise sterile and non-sterile drug manufacturing facility in Indre Et Loire, France. The specific observations were: * procedures designed to prevent microbiological contamination of products purporting to be sterile do
Drugs
Novo Nordisk has filed a supplemental NDA seeking approval for a higher-dose version of its weight-loss drug Wegovy (semaglutide). If approved, the company says the 7.2 mg option could deliver even greater weight loss than the blockbuster drug’s existing 2.4 mg formulation. The drugmaker says
Drugs
A recent Washington University Law Review article suggests a framework the courts could use for the “next preemption frontier” of state challenges to FDA actions through conflicting regulations. The article, by New York University School of Law professor Catherine Sharkey and federal court for the Southern District of New York
Drugs
An 8/4-8/7 FDA inspection at Hong Qiangxing Shenzhen Electronics in Shenzhen, Guangdong, China, found Quality System Regulation violations in the firm’s manufacturing of wrist blood pressure monitors, transcutaneous electric nerve stimulators, and powered muscle stimulator devices. A just-released 10/28 Warning Letter says the specific
Drugs
A 3/25-3/27 FDA inspection at the Owen Biosciences drug manufacturing facility in Baton Rouge, LA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/20 Warning Letter says the specific violations were: * failure to establish laboratory controls that include
FDA Policy/General
FDA has issued a draft guidance, Cross-Center Master Files: Where to Submit, with recommendations for master file holders about to which Center a master file is to be submitted (1) that is referenced in and intended to support more than one regulatory submission for which the lead Center for
FDA Policy/General
National Center for Health Research president Diana Zuckerman says FDA commissioner Marty Makary’s plan to rely on “spontaneous [and] robust” expert panels rather than advisory committees misses the point on the value of advisory committees and undermines the credibility of agency decisions. Writing in a Medpage Today opinion column,
Drugs
Novo Nordisk is reporting favorable Phase 2 data for its investigational dual-action obesity and diabetes drug amycretin, showing significant reductions in both weight and blood sugar among adults with Type 2 diabetes inadequately controlled on standard therapies. The study marks the first time amycretin has been tested in a