Drugs
FDA has released a 10-item Form FDA-483 related to an inspection last month at SCA Pharmaceuticals’ Windsor, CT outsourcing facility that cited significant GMP deficiencies. For example, the agency took issue with the firm’s lack of quality control efforts because it does not require identification of particulates
Drugs
FDA has accepted for review a Karuna Therapeutics NDA for KarXT (xanomeline-trospium) for treating schizophrenia in adults. The agency has set a 9/26/2024 review action target date. Karuna says the submission is based on data from the company’s EMERGENT clinical trial program. “In all three placebo-
Drugs
The American Society of Hematology says it commends FDA for releasing its draft guidance on developing products to prevent or treat graft-versus-host disease (GVHD). The society comment letter says investigators and hematologists conducting stem cell transplants can benefit from the guidance on acute and chronic GVHD. “To ensure
Drugs
CDER researchers simulating how factors may affect corticosteroid nasal deposition say that on average, more than 94% of the medication went into the nasal cavity. “At least 91% of all drug mass entered the nose,” an online post says. “Overall, the different sprays had little effect on medication distribution.” The
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Several Skadden attorneys say an increased focus on cybersecurity could pose False Claims Act (FCA) exposure risk for life sciences companies. Writing in a lengthy online newsletter, the attorneys review FDA’s promotional enforcement update, Warning Letters arising out of inspection activities, and a loss on statutory interpretation. The report
Drugs
A 5/1-5/12 FDA inspection at the Intas Pharmaceuticals drug manufacturing facility in Matoda-Sanand, Ahmedabad, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs, many of which were similar to those from an earlier inspection. An 11/21 Warning Letter says specific
Drugs
FDA is warning of a rare but serious drug reaction to two anti-seizure medications — levetiracetam (UCB’s Keppra and Keppra XR, TriPoint Therapeutics’ Elepsia XR, and Aprecia Pharmaceuticals’ Spritam) and clobazam (Lundbeck Pharmaceuticals’ Onfi and Otter Pharmaceuticals’ Sympazan). An agency drug safety communication says the reaction is called Drug
Drugs
Acelyrin says it is contracting with an independent auditor to review trials of izokibep being conducted by a contract research organization for the company, including a psoriatic arthritis trial and a moderate-to-severe hidradenitis suppurativa trial. The planned audit follows reports of clinical trial execution errors by the research
Drugs
FDA says its review of a Web site maintained by Dr. Berne’s Whole Health Products in Tesuque, NM, determined that the site offers three illegal eye drop products for sale in the U.S. An 11/22 Warning Letter says the products are unapproved new drugs and are adulterated.
Drugs
President Biden has announced that his administration will invoke the Defense Production Act to manufacture essential medicines in the U.S. to mitigate drug shortages. A Presidential Determination is planned to be issued to give HHS broader authority to “enable investment in domestic manufacturing of essential medicines, medical countermeasures, and
Drugs
FDA and the Duke-Margolis Center for Health Policy are holding a hybrid (online/in-person) public meeting 1/31 on “Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches.” The meeting is intended to discuss with stakeholders
Drugs
Researchers say a pilot program using a mixed reality device with a collaborative text messaging system allowed multiple national regulatory authorities, including FDA, to perform a regulatory inspection of a good manufacturing practice (GMP) facility simultaneously, while still following their respective internal procedures. Writing in Therapeutic Innovation & Regulatory Science,
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FDA has sent Aldeyra Therapeutics a complete response letter on its NDA for reproxalap, an investigational drug candidate for treating dry eye disease. The letter said the submission did not demonstrate “efficacy in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well-controlled
Drugs
Novartis has recalled two lots of its Sandimmune oral solution (cyclosporine) 100 mg/mL due to crystal formation observed in some bottles, which could result in incorrect dosing. The issue was identified during an investigation of crystallization in a different Sandimmune lot, according to a recall notice. The drug is
Drugs
In an 11/21 brief, FDA urges the Supreme Court to hear an appeal of the 5th Circuit Court of Appeals decision that sharply restricts distribution of the chemical abortion pill mifepristone (Danco’s Mifeprex). The filing says the 5th Circuit’s decision contradicts fundamental principles of Article III of
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FDA has approved an Evive Biotech BLA for Ryzneuta (efbemalenograstim alfa), indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. Approval was based on data from two pivotal Phase 3 Studies, GC-627-04 [NCT02872103] and
Drugs
Entrada Therapeutics says that despite providing additional information to FDA, an ongoing clinical hold against the company’s Phase 1 trial of ENTR-601-44 in Duchenne muscular dystrophy (DMD) patients remain in effect. “Importantly, the information that was submitted to the FDA supported the initiation of the Phase 1
Drugs
An eastern California federal grand jury has returned a three-count indictment against Jia Bei Zhu, aka Jesse Zhu, Qiang He, and David He, a citizen of China who formerly resided in Clovis, CA, charging him with distributing adulterated and misbranded medical devices in violation of the federal Food, Drug,
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned by an FDA proposal to eliminate the parallel interchangeability statement and footnote currently in the labeling of some biosimilar products listed as interchangeable. The proposal is part of an agency draft guidance on labeling for biosimilar and interchangeable biosimilar
Drugs
A 2/6-2/17 FDA inspection at the Cipla drug manufacturing facility in Madhya Pradesh, India, found repeat significant current good manufacturing practice (CGMP) violations for finished drugs. An 11/17 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch
Drugs
Writing in National Law Review, three Epstein Becker Green attorneys say medical product manufacturers should study an FDA 2023 draft guidance on sharing scientific information with healthcare providers on unapproved uses of medical products “to mitigate potential risk in navigating the often murky regulatory waters of engaging in off-label
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A 12/6-12/15/2022 FDA inspection at a clinical trial site operated by Dr. Melanie Hoppers/Physicians Quality Care in Jackson, TN, found objectionable conditions in the conduct of two clinical investigations. An 11/8 Warning Letter says it appears that Hoppers did not adhere to the applicable