FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “‘Considerations in Demonstrating Interchangeability With a Reference Product: Update.” The document describes considerations about a switching study or studies intended to support a demonstration that a proposed therapeutic protein product is interchangeable with a reference product. FDA says regulatory
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection.” The document reflects changes in the FDA Reauthorization Act of 2017 so that, as is the case with a drug, a device is deemed to be
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Human User Safety in New and Abbreviated New Animal Drug Applications.” The document addresses general principles of human user safety (HUS) assessment for new animal drugs, sources of data, mitigation strategies for proposed new animal drugs, potential recommendations to
Drugs
FDA is announcing a 7/22 public workshop on “Best Practices for Meeting Management Under PDUFA VII.” The agency says that with increasing interaction meetings available to industry, “optimizing meeting management practices has become more important to facilitate the conduct of efficient and effective drug development programs.” Under the user
Drugs
Eli Lilly says it has submitted an NDA for weight loss therapy Mounjaro (tirzepatide) for treating moderate-to-severe obstructive sleep apnea (OSA) and obesity, and it expects a regulatory decision by the end of the year. The submission is based on data from the SURMOUNT-OSA Phase 3 clinical
Drugs
Lexicon Pharmaceuticals says that after receiving recent FDA feedback it has resubmitted its NDA for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, as an adjunct to insulin therapy in patients with Type 1 diabetes and chronic kidney disease (CKD). In 2021, CDER issued a Federal Register notice proposing
Biologics
CBER director Peter Marks has again overridden his Center’s review teams in expanding the limited approval of Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy Elevidys to full approval. On 6/20, Marks signed off on the supplemental BLA and dismissed reviewers’ objections to broaden Elevidys’ use to about
Devices
Zoll Medical has recalled (Class 1) its Zoll 731 Ventilators (EMV+, AEV, Eagle II MRI compatible devices) and their operator and quick reference guides. A recall notice says the guides omit patient safety ventilator MRI information, and they are being updated with instructions to ensure safe distance from the MRI
Drugs
FDA has lifted a 2022-ordered partial clinical hold on PTC Therapeutics’ PTC518 for treating Huntington’s disease based on the agency’s review of Phase 2 trial data (PIVOT-HD). The company says interim results from the study showed that at “month 12, PTC518 treatment resulted in dose-dependent
Drugs
FDA has approved a major modification to the Risk Evaluation and Mitigation Strategy (REMS) for Kite Pharma’s lymphoma drugs Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). An agency notice says FDA has determined that the REMS must be modified to minimize the burden on the healthcare delivery system of
Drugs
A 5/30-6/7 FDA inspection at the Dr. Reddy’s Laboratories active pharmaceutical ingredient manufacturing facility in Andhra, Pradesh, India has four inspection observations. FDA has released the form FDA-483 issued following the inspection with these observations: * failure to validate or verify analytical methods under the actual
Drugs
FDA has published a guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection, meeting a requirement for such a guidance in the 2012 FDA Safety and Innovation Act. The document finalizes a 12/16/2022 draft guidance and supersedes a 10/2014 guidance, which is
Biologics
FDA is moving away from recommending switching studies to support an interchangeability determination for biosimilar products. In a just-published draft guidance, the agency is seeking comments on a revised approach where such studies will generally not be needed. FDA’s recommendation for switching studies first appeared in its interchangeability
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 20 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested they be withdrawn. To view the notice, click here.
Drugs
Jazz Pharmaceuticals says top-line results from its Phase 2b clinical trial (NCT05122650) evaluating the efficacy and safety of suvecaltamide in adult patients with essential tremor did not achieve statistical significance at 30mg versus placebo on the primary endpoint of change from baseline to week 12 on the Essential Tremor
Drugs
Johnson & Johnson has submitted an sBLA to FDA for approval of its Tremfya (guselkumab) to treat adults with moderately to severely active Crohn’s disease. A company statement says that it also submitted an sBLA in March for an indication to treat severely active ulcerative colitis. The Crohn’s
Devices
FDA has granted Onkos Surgical a de novo authorization for its novel antibacterial coating for use with implants. “Implant contamination is a growing concern to the orthopedic surgical community,” the company says. The coating technology was authorized based on data showing that the “proprietary coating does not elute and has
Drugs
FDA has approved a new indication for AbbVie’s Skyrizi (risankizumab-rzaa) to treat moderate to severe ulcerative colitis. The company says the approval was supported by two Phase 3 trials, the INSPIRE 12-week induction trial and the COMMAND 52-week maintenance study. Skyrizi is described as an interleukin-
FDA Policy/General
Federal Register notice: FDA is correcting a 3/29 notice on the approval withdrawals of 30 ANDAs from multiple applicants, effective 4/29. The document in error indicated that five ANDAs held by Target Health were being withdrawn. However, Target had timely requested that the approvals not be withdrawn, and
FDA Policy/General
FDA has published a guidance, Human User Safety in New and Abbreviated Animal Drug Applications, clarifying the current approaches and recommendations the Center for Veterinary Medicine (CVM) uses for human user safety (HUS) assessment and submission of HUS information to support the overall safety of proposed new animal drugs before
Drugs
FDA is notifying NDA and ANDA sponsors that clinical and bioanalytical studies conducted by Synapse Labs Pvt. Ltd. in Pune, India, are not acceptable due to data integrity concerns. An agency online notice says that studies conducted by Synapse must be repeated. “During analyses of study data generated at Synapse
Drugs
Several stakeholders are expressing their appreciation for FDA’s issuance of a draft guidance, Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products. Flatiron Health says the draft will give sponsors and real-world data (RWD) organizations clarity in regulatory expectations in designing a non-interventional