FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Cara Therapeutics’ Korsuva (difelikefalin acetate), indicated for treating moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The regulatory review period is 4,625 days, of which 4,381 days occurred
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for G1 Therapeutics’ Cosela (trilaciclib), indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topetecan-containing regimen for extensive-stage small cell lung
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Shortages Data Collections.” The collection supports agency regulations giving CDRH authority to acquire and maintain detailed data on domestic inventory, manufacturing capabilities, distribution plans, and raw material constraints for medical devices that would be in high demand
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.
Devices
FDA says it is investigating an identified risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies, and is evaluating the need for regulatory action. The agency says it has received reports of T-cell malignancies, including CAR-positive lymphoma, in
Devices
FDA has issued a warning on Philips’ DreamStation 2 continuous positive airway pressure (CPAP) machines and their potential to overheat. The agency says patients and healthcare providers should carefully monitor the devices for signs of overheating based on medical device reports (MDRs) it has received recently about thermal issues such
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,
Devices
FDA has withdrawn its membership in the 32-member medical device Global Harmonization Working Party (GHWP), which is chaired by China, after failing to persuade the organization to align with other international harmonization efforts, such as the International Medical Device Regulators Forum (IMDRF). “Moving forward, FDA will spend the next
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled Good Laboratory Practice (GLP) Requirements for Nonclinical Laboratory Studies — 21 CFR Part 58. The collection supports agency regulations that specify minimum standards for the proper conduct of safety testing. They also address facilities, personnel, equipment, standard operating
Devices
Unomedical is recalling certain VariSoft Infusion Sets due to the risk that the device’s connector may detach from the set which would disrupt insulin delivery. “If this occurs, insulin may continue to flow through the tubing that is now disconnected from the patient and the insulin pump would not
Biologics
FDA has accepted for priority review an Abeona Therapeutics BLA for pz-cel (prademagene zamikeracel) autologous COL7A1 gene-corrected epidermal sheets for treating patients with recessive dystrophic epidermolysis bullosa (RDEB). The agency has set a 5/25/2024 review action target date, according to the company, adding that an advisory
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Covid-19: Developing Drugs and Biological Products for Treatment or Prevention.” The document describes FDA’s current recommendations for Phase 2 and Phase 3 trials with a focus on trial population, trial design, efficacy endpoints, safety considerations, and statistical
Drugs
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
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a 10/24 notice on the revised draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” Comments can now be submitted until 1/5/2024.
Biologics
CBER director Peter Marks and CDC National Center for Emerging and Zoonotic Infectious Diseases director Daniel Jernigan say the Vaccine Adverse Event Reporting System (VAERS) their agencies co-manage “works and has a track record that proves it.” The two wrote an online FDA Voices post that “explains how VAERS
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
Drugs
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