Devices
FDA is alerting health care providers about an import alert for certain Olympus Medical Systems medical devices manufactured in Japan. “Despite extensive and ongoing efforts to address compliance issues, the FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus,” the agency says. “Therefore, the FDA
Drugs
A new analysis by Hogan Lovells finds CDER enforcement activities are “substantially larger, broader in scope, and more centralized than they were two years ago. Moreover, the composition of enforcement activity has shifted in ways that should prompt pharmaceutical manufacturers to reassess their compliance risks.” Examining CDER Office of Compliance’
Drugs
FDA granted traditional approval to Merck’s Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for certain patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors, while raising the biomarker threshold used to determine eligibility for treatment. The approval covers adult and pediatric patients
Drugs
Bipartisan legislation intended to accelerate the development of rare disease treatments by making clinical trials faster, cheaper, and more accessible to patients was to be introduced in the House on 10/22 by Reps. Jake Auchincloss (D-MA) and Morgan Griffith (R-VA). CNBC Cures reports that the Faster Clinical
Drugs
FDA has released the 27-page Form FDA-483 with six observations from a 5/4-5/15 inspection at the Mylan Laboratories drug manufacturing facility in Maharashtra, India. The inspection observations were: * failure to fully follow the responsibilities and procedures applicable to the quality control unit; * failure to exercise
FDA Policy/General
The Partnership for Safe Medicines (PSM) has filed a citizen petition urging FDA to ban compounding of unapproved peptides and to disregard the advisory committee vote that recommended allowing them. The advocacy group contends the committee was constituted in violation of the Federal Advisory Committee Act and the Ethics in
Drugs
The Association for Accessible Medicines (AAM), which represents America’s generic and biosimilar drug sector, says it “strongly supports” the proposed GDUFA 4 commitment letter outlining the agreement negotiated between FDA and the industry. “GDUFA has played an essential role in strengthening the generic drug review process, helping to ensure
Drugs
The U.S. Justice Department says Jeffrey McIndoo (Phoenix, AZ) and his company, JeffMac Investments LLC doing business as SARMS Pharm LLC , were sentenced following prior guilty pleas over the alleged illicit sale of potentially dangerous chemical substances known as selective androgen receptor modulators (SARMs). SARMS mimic the effects of
Drugs
BDR Pharmaceuticals International has filed a lawsuit against FDA, alleging the agency unlawfully extended market exclusivity for Phathom Pharmaceuticals’ acid-suppressing drug Voquezna (vonoprazan), preventing BDR from submitting an ANDA for a generic version until 5/2032. In a 10/21 complaint filed in the U.S. District Court for
FDA Policy/General
FDA's expanding transparency initiative could significantly change how pharmaceutical and biotechnology companies evaluate potential acquisitions, giving buyers greater access to regulatory information that could influence asset valuations, purchase agreements and the allocation of financial risk, according to attorneys at Arnall Golden Gregory (AGG). Earlier this month, FDA unveiled
Independent news and analysis of FDA regulation, policy and enforcement
Three Democratic senators are turning up the heat on FDA to explain its response to widespread shortages of estradiol transdermal patches used to treat menopause symptoms, questioning why the agency has not formally declared a shortage and demanding details about plans to expand manufacturing capacity. Last month, FDA said it
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the draft PDUFA 8 commitment letter. The PhRMA comment says PDUFA 8 will help ensure the long-term sustainability of FDA’s human drug review program and strengthen agency capabilities by: * enhancing the efficiency of the drug review process
CDRH is accelerating hiring after losing about 22% of its workforce over the past year and a half, including up to 30% of its clinical reviewers and significant numbers of artificial intelligence and digital health specialists. CDRH drector Michelle Tarver disclosed the staffing losses 10/21 at AdvaMed's
The Bipartisan Policy Center (BPC) says it supports FDA’s goal of a risk-based, least-burdensome approach that gives patients timely access to safe and effective generative artificial intelligence (AI) device functions. Responding to an FDA discussion paper on the subject, BPC makes these key points: * several approaches in
Researchers from Johns Hopkins and the University of Miami say myelodysplastic syndromes (MDS) therapeutic development is challenged by the syndromes’ biological diversity and regulatory risk. Writing in Blood Advances, the researchers say MDS is “ideal for FDA to implement flexible, biology-informed regulatory pathways. Establishing such frameworks in MDS could
A Georgia federal court has determined that FDA misread its own regulations in determining that a MiMedx wound care powder product was not a human cell, tissue, or cellular- or tissue-based product (HCT/P) because it was not minimally manipulated. Attorneys Vanessa Hampton and Alan Minsk (Arnall Golden Gregory)
FDA has released the Form FDA-483 with eight observations from a 6/8-6/17 inspection at the Jubilant HollisterStier drug manufacturing facility in Spokane, WA. The inspection observations were: * component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for
FDA investigators have cited Catalent CTS for deficiencies in contamination prevention and microbial monitoring at its Kansas City, MO, drug manufacturing facility, including multiple water leaks and a failure to investigate a potentially objectionable microorganism detected in a manufacturing system. The findings were detailed in a just-posted Form FDA
FDA has released the Form FDA-483 with one observation from a 5/12-5/19 inspection at the Lonza Bend manufacturing facility in Bend, OR. The inspection observation was: * failure to thoroughly review any unexplained discrepancy, whether or not the batch had already been distributed.
Roivant and Priovant Therapeutics have announced positive results from the Phase 3 CLARITY program evaluating brepocitinib in non-infectious uveitis (NIU). The drug met the primary endpoint for both the CLARITY-1 and CLARITY-2 studies, according to the company. It also achieved “statistically significant and clinically meaningful benefit on
FDA has accepted for review a Unicycive Therapeutics NDA resubmission for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The submission addresses a June Complete Response Letter (CRL) that cited deficiencies previously identified at a third-
FDA has issued a warning letter to Baxter International citing significant GMP deficiencies at its Round Lake, IL, manufacturing facility, including recurring cross-contamination involving cephalosporin antibiotics, inadequate sterile manufacturing controls, particulate contamination and failures to properly investigate sterility test results. The just-posted 9/29 Warning Letter, which followed