Drugs
FDA has announced a 4/19 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a postmarketing requirement (PMR) issued to NDA application holders for extended-release and long-acting opioid analgesics. The PMR is intended to evaluate the products’ long-term efficacy and the risk of opioid-induced
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FDA has lifted a clinical hold against Astellas Pharma and its FORTIS Ph1/2 clinical trial evaluating AT845, an adeno-associated virus gene replacement therapy in adults with late-onset Pompe disease. The hold was placed 6/27/2022 following a report of peripheral sensory neuropathy in one of the
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The International Conference on Harmonization (ICH) has released a final guide entitled Quality Risk Management Q9 (R1), which has been adopted by FDA for implementation. The document is intended to offer a systematic approach to quality risk management that leads to better informed decisions. “It serves as a foundation or
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House Energy and Commerce Committee ranking member Frank Pallone (D-NJ) has written to FDA and the National Institutes of Health (NIH) with a concern about the “lack of compliance by medical product sponsors with requirements to report certain clinical trial results information to the ClinicalTrials.gov database.” His 1/
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FDA has denied a 7/22/22 Fresenius Kabi petition asking the agency to designate the company’s glycopyrrolate intramuscular, intravenous solution 0.6 mg/3 mL as therapeutically equivalent (TE) with an AP rating to Hikma Pharmaceutical’s Robinul (glycopyrrolate injection 0.2 mg/mL). The agency’s 1/
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Attorneys James Bolani and Bonnie Odom (Epstein Becker Green) say a small section buried in the Consolidated Appropriations Act of 2023 clarified the regulatory status of contrast agents, radioactive drugs, and over-the-counter monograph drugs. “The new law brings to an end the uncertainty regarding the regulatory status of
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FDA has asked a Florida federal court to issue a permanent injunction against LGM Pharma, headquartered in Boca Raton, FL, and two of its executives. The agency’s 1/11 complaint says LGM imports and distributes drugs, including active pharmaceutical ingredients, from a facility in Erlanger, KY. FDA inspected the
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FDA has released the form FDA-483 issued following an 11/22-12/2/22 inspection at Intas Pharmaceuticals in Ahmedabad, Gujarat, India. The 11 inspection observations were: * laboratory records do not include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and
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FDA commissioner Robert Califf says a major reformation of our national system for generating medical evidence — the clinical research enterprise — is needed to facilitate the translation of biomedical research into useful products and interventions. Writing in the journal Clinical Trials, Califf says that currently premarket systems for generating and evaluating
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The Biotechnology Innovation Organization (BIO) recommends ways FDA could strengthen its International Council for Harmonization Q5A draft guidance on evaluating the viral safety of biotechnology products derived from cell lines of human or animal origin. The association’s comment letter recommends that FDA: * clarify the role/conduct of new molecular
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FDA has denied a 2/2022 citizen petition from advocacy group Public Citizen that urged it and the Drug Enforcement Administration (DEA) to open proceedings to place gabapentin (Almatica Pharma’s Gralise and Pfizer’s Neurontin) and gabapentin enacarbil (Arbor’s Horizant) into Schedule V of the Controlled Substances Act.
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Merck says it has identified the root cause of nitrosamine (NTTP) formation in certain Januvia (sitagliptin) batches, and it has provided a detailed report to FDA and other health authorities The drug is indicated for treating Type 2 diabetes mellitus. Last year, FDA said it became aware of the nitrosamine
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FDA is asking a Texas federal court to deny a request for a preliminary injunction sought by the Alliance for Hippocratic Medicine and others to reverse the FDA 2000 determination that mifepristone is safe and effective for the medical termination of intrauterine pregnancy under certain conditions. FDA’s filing in
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SFJ Pharmaceuticals says it has closed the sale and transfer of assets related to bentracimab from PhaseBio Pharmaceuticals as part of a bankruptcy proceeding, and it is planning to file a BLA mid-year. Since 2020, the two companies had been co-developing bentracimab, a recombinant, human monoclonal antibody antigen-
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The Government Accountability Office (GAO) says HHS could improve its oversight of research involving enhanced potential pandemic pathogens. The GAO report faults a six-year-old HHS oversight framework that requires funding agencies to refer proposed research that is reasonably anticipated to create, transfer, or use enhanced potential pandemic pathogens
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The CDER Office of Pharmaceutical Quality (OPQ) says two Quality Management Maturity (QMM) pilots provided insights into how to design and implement a future QMM assessment protocol. Writing in the APPS Journal, OPQ staff say the program will continue to be developed with stakeholder input. “CDER is committed to providing
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CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim says the Biosimilar User Fee Amendments 3 commitment letter includes goals for FDA to create foundational guidances for interchangeable biosimilar biological product development. Writing in an online CDER Conversation post, Yim says the intent is to develop guidances that cover
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A Florida woman was sentenced to three years in prison and three years of supervised release for making a false statement to an FDA investigator related to a clinical trial that studied the effectiveness of asthma drugs in children. The Department of Justice says Jessica Palacio of Miami was sentenced
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The DC Circuit Court of Appeals says Sandoz is not entitled to a solo period of marketing exclusivity for its generic version of Sanofi’s Aubagio (teriflunomide). Sandoz challenged the new chemical entity exclusivity granted to Aubagio, claiming that teriflunomide was previously “approved” as an impurity in the arthritis drug
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FDA is announcing a 3/8 workshop entitled “Understanding the Use of Negative Controls to Assess the Validity of Non-Interventional Studies of Treatment Using Real-World Evidence.” The workshop, which is mandated by the current drug user fee agreement, will be hosted by the Duke-Margolis Center for Health
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A 3/8-3/18/22 FDA inspection at Optum Infusion Services in Chandler, AZ, found “serious deficiencies” in the firm’s practices for producing drug products intended or expected to be sterile, which put patients at risk. A just-released 12/13/22 Warning Letter says the FDA inspector
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FDA has expanded its collaboration with CN Bio, described as a leading “organ-on-a-chip” company, for the second time. A company statement says the expanded collaboration will involve new research intended to evaluate multi-organ microphysiological systems and their applications using the PhysioMimix multi-organ system. “Building on