Improve FDA Myelodysplastic Syndromes Guidance

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

Court Rejects FDA HCT/P Designation

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)

8 Observations on Jubilant HollisterStier Form FDA-483

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 Cites Catalent Plant Over Water Leaks, Microbial Monitoring

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

Lonza Bend Form FDA-483 Out

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/Priovant Report Positive Data on Non-Infectious Uveitis Drug

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

Unicycive Resubmits NDA for Hyperphosphatemia Drug

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 Warns Baxter Over GMP Issues at Injectable Drug Plant

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

Senators Urge FDA to Crack Down on ‘Research Use Only’ Drugs

Sen. Jim Banks (R-IN) is leading a group of senators urging FDA to ramp up enforcement against online vendors using “for research use only” labeling to market unapproved drugs and active pharmaceutical ingredients (APIs) to consumers, citing growing concerns about counterfeit versions of Eli Lilly’s investigational weight-loss

FDA Guidance on Drug-Related Software, Labeling Requirements

FDA has finalized a guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software that outlines how prescription drug manufacturers should address software applications used with their products, including when claims about the clinical benefits of such software can be included in FDA-approved drug labeling. The guidance addresses mobile

Device QMSR Fears Easing: Panel

Industry executives and FDA officials who participated in a 10/19 panel at The MedTech Conference say initial industry concerns about the new Quality Management System Regulation (QMSR) and its implementation by FDA are easing as companies get more experience with inspections under the new protocol. A Regulatory Affairs Professionals

FDA Approves GSK’s Hibsago for Chronic Hepatitis B

FDA has approved GlaxoSmithKline’s Hibsago (bepirovirsen) to treat chronic hepatitis B virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at least six months, who have suppressed HBV deoxyribonucleic acid (DNA), and with hepatitis B