FDA shifts its scrutiny of Johnson & Johnson’s OTC drug quality control onto the firm’s consumer devices, including K-Y moisturizers, after finding shortcomings in post-market monitoring and pre-market notification. The agency’s May 22 warning letter does not cite manufacturing issues.
FDA shifts its scrutiny of Johnson & Johnson’s OTC drug quality control onto the firm’s consumer devices, finding sufficient shortcomings in post-market monitoring and pre-market notification to warrant a warning letter.
J&J and subsidiary McNeil Consumer Healthcare say they have come a long way in improving management of OTC pharma...
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One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.
Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.
The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.
The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.
The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.
Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.
Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
