Devices
FDA has issued an early alert warning healthcare providers about a potentially high-risk problem involving certain anesthesia workstations manufactured by Drager that could cause mechanical ventilation failure during use. The alert affects the company’s Atlan A350 and Atlan A350 XL anesthesia workstations, which are used during surgical and
Drugs
FDA has approved Genentech’s Tecentriq (atezolizumab) and a subcutaneous formulation of the drug for the adjuvant treatment of certain patients with muscle-invasive bladder cancer who test positive for circulating tumor DNA after surgery. The approval covers adults with muscle-invasive bladder cancer who have undergone cystectomy and are
Drugs
FDA says Sun Pharma is recalling one batch of 675 vials of DOXOrubicin hydrochloride liposome injection 50mg/25mL with an expiration date of 5/2027. An agency notice says the batch was recalled on 5/13 due to the detection of glass particles in some vials during production. A Sun
FDA Policy/General
While many health policy experts have expressed concerns that FDA will suffer under the Supreme Court’s Loper Bright decision because judges will be interpreting scientific and health-related terms rather than deferring to FDA’s judgment, University of Missouri law professor Erika Lietzan thinks Loper Bright “may not be
Drugs
CDER has published a Manual of Policies and Procedures (MAPP) on Assessing Impurity Acceptance Criteria as Part of Specifications for NDAs, ANDAs, and BLAs Based on Clinical Relevance. “While the ICH guidance for industry Q3A(R2) Impurities in New Drug Substances (June 2008) and the ICH guidance for industry Q3B(
Drugs
The sudden resignation of FDA commissioner Marty Makary capped one of the shortest and most turbulent FDA tenures in recent memory, with media reports over the past two days painting a portrait of an agency consumed by political warfare, regulatory uncertainty and internal upheaval. Makary formally stepped down Tuesday after
Drugs
AstraZeneca says perioperative treatment with Imfinzi (durvalumab) combined with neoadjuvant enfortumab vedotin (EV) (Astellas/Pfizer's Padcev) significantly improved event-free survival and overall survival in patients with muscle-invasive bladder cancer who were ineligible for or declined cisplatin chemotherapy, according to interim Phase 3 VOLGA trial results released
Devices
A newly filed citizen petition is urging FDA to take enforcement action against the BariClip, an implantable bariatric device that petitioners say is being marketed and used in the U.S. without FDA authorization. The device, which is manufactured by Advanced Bariatric, is described as a reversible, non-cutting alternative
Drugs
Americans for Scientific Integrity is petitioning FDA to amend the labeling requirements for over-the-counter acetaminophen-containing drug products to include warnings about their potential effects on fertility and reproductive development. The petition says the advocacy group “does not assert a causal relationship has been definitively established between acetaminophen
Drugs
FDA has released a draft guidance outlining recommendations for drugmakers developing local anesthetic products designed to provide prolonged postoperative pain relief, as the agency seeks to support alternatives to opioid-based pain management. The draft guidance, titled “Development of Local Anesthetic Drug Products With Prolonged Duration of Effect,” focuses on
Drugs
Three Morgan Lewis attorneys say the FDA 3/11 launch of its new Adverse Event Monitoring System (AEMS) “marks an important evolution in safety data transparency and accessibility, offering single-platform advanced analytics and real-time information for drugs, biologics, cosmetics, and vaccines, with medical device data to be added
Drugs
FDA has published draft guidances addressing the development of non-opioid analgesics and considerations for a benefit/risk assessment framework for opioid analgesics. The guidance on developing non-opioid analgesics for chronic pain addresses two FDA priorities — (1) fostering the development of novel analgesic products and (2) decreasing opioid analgesic
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad for BeOne Medicines’ Brukinsa (zanubrutinib) capsules and tablets is false and misleading and thus misbrands the drug. A 5/12 Notice of Violation says the totality of claims and presentations made through visuals in the ad “misleadingly suggests
FDA Policy/General
The departure of FDA commissioner Marty Makary “comes as a positive move after a period of turmoil in the biotech sector, but until a permanent replacement is found, the industry could be under pressure, according to analysts and investors” who were interviewed for a Reuters analysis. The news service has
Drugs
FDA has issued a draft guidance detailing how the agency will evaluate the benefits and risks of new opioid analgesic drugs, emphasizing that approval decisions will consider not only patient outcomes but also broader public health effects such as misuse, abuse, overdose, and opioid use disorder. The draft guidance, “Opioid
FDA Policy/General
FDA’s newly announced pilot program for one-day inspectional assessments (see earlier story) may signal a long-term shift toward faster, AI-assisted oversight of regulated facilities, according to an analysis published by law firm King & Spalding. FDA formally announced the pilot program on 5/6, though the
Drugs
An FDA review of websites maintained by Navah Pharma/Bigdam Inc, based in Netanya, Israel (Navah) and Atlanta, GA (Bigdam), determined that the firms are selling unapproved new drugs through several online websites. A 5/4 Warning Letter says the Websites are selling RSV Hypertonic Saline 3% and Hypertonic Saline
FDA Policy/General
FDA commissioner Marty Makary has resigned after a week of mounting speculation that the Trump Administration was preparing to remove him. The resignation follows several days of reports that President Trump had approved plans to dismiss Makary over conflicts involving flavored vape approvals, abortion-pill policy, vaccine oversight and broader
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that an FDA draft guidance on responding to form FDA-483 observations at the end of a drug CGMP inspection “could be interpreted to go beyond the topic … and to suggest new substantive CGMP expectations.” The comment letter asks
Drugs
CDER is requesting information for a planned regulatory science initiative to advance biomarker validation through the compilation of data from multiple sources and through a specific pilot project focused on aggregating data for biomarkers of drug-induced kidney injury. A 5/13 Federal Register notice says ultimately, improving CDER’s
Drugs
FDA says Ipsen will voluntarily withdraw its cancer drug Tazverik (tazemetostat) from the U.S. market after new clinical trial data showed an increased risk of serious secondary blood cancers in patients receiving the therapy. In a safety alert, the agency said treatment with Tazverik was associated with higher rates
Drugs
FDA has cited SCA Pharmaceuticals for multiple manufacturing and contamination-control deficiencies at its outsourcing facility in Windsor, CT, including failures involving sterile compounding practices, particulate contamination investigations and environmental monitoring. According to a just-posted FDA Form 483 issued following an inspection conducted in March, investigators found that procedures