Drugs
A new report from the National Academies of Sciences, Engineering, and Medicine calls on FDA, HHS, the National Institutes of Health, and Congress to act to improve the inclusion of pregnant and lactating women in clinical trials. The document says such women are often excluded from clinical trials due to
Devices
In the latest move by FDA in its ongoing investigation into the quality of syringes made in China, the agency is announcing expanded actions against Jiangsu Shenli Medical Production Co. Ltd. with an additional import alert for not meeting device quality system requirements. The import alert is intended to prevent
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the goal of an FDA public meeting to facilitate a discussion of the use of external data sources, Bayesian statistical methods, and modeling and simulation supporting clinical trial complex innovative designs (CIDs), and to explore examples of how CIDs are
Drugs
A 10/12-10/20/2023 FDA inspection at the Kilitch Healthcare India drug manufacturing facility in Mumbai, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/28 Warning Letter says the firm’s drugs were adulterated because they were prepared, packed, or
Drugs
FDA’s review of records submitted by Jiangsu Meifan Biotechnology Co. Ltd., a manufacturer of over-the-counter drug products in Jiangsu, China, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/3 Warning Letter says specific violations were: * failure to have, for each
Drugs
FDA has granted Phanes Therapeutics a fast track designation for PT217 and its use in treating patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor. PT217 was previously granted orphan drug status for treating SCLC in 2022.
Drugs
Harvard Medical School researchers say most cancer drugs granted FDA accelerated approval did not demonstrate benefit in overall survival or quality of life within five years of the accelerated approval. Writing in JAMA, the researchers conclude that “patients should be clearly informed about the cancer drugs that use the accelerated
FDA Policy/General
Federal Register notice: FDA is making available its annual compilation of update notices to the agency’s Susceptibility Test Interpretive Criteria Web page. The Web site and subsequent annual posting are mandated by the 21st Century Cures Act, which clarified FDA’s authority to identify and efficiently update susceptibility test
Drugs
BrainStorm Cell Therapeutics says it has received an FDA written agreement under a Special Protocol Assessment on the design of its planned Phase 3b trial of NurOwn in amyotrophic lateral sclerosis (ALS). The SPA agreement “validates the clinical trial protocol and statistical analysis” of the planned trial, “demonstrating their adequacy
Drugs
An 11/13-11/17/2023 FDA inspection at the Antaria Pty. Ltd. drug manufacturing facility in Queensland, Australia, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 3/22 Warning Letter says specific deviations were: * failure to adequately investigate and document out-
Drugs
The Congressional Research Service (CRS) says a recent Court of Federal Claims ruling in a case brought by Vanda Pharmaceuticals against FDA raises issues of interest to Congress that could result in new legislation. In a Legal Sidebar, CRS describes the case in which Vanda claimed that FDA violated its
Devices
Ten members of an FDA advisory committee evaluating an Abbott heart device had financial ties to the company, according to a KFF Health News report carried by NBC. The media outlet used the federal government’s Open Payments database to find that one committee member was linked to hundreds of
FDA Policy/General
Researchers in the CDER Office of Prescription Drug Promotion say they found that prominently disclosing information related to the methodological rigor of a study may help healthcare professionals form an accurate perception of the strength of the study and support for any claims that may be in promotional communications. The
Drugs
FDA has issued Alkem Laboratories a 10-observation Form FDA-483 after inspecting the firm’s Baddi, Himachal Pradesh, India manufacturing facility last month. The agency inspection cited Alkem for failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet
Devices
A federal court has approved an FDA-brokered consent decree against Philips Respironics over its defective continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines, and other devices. CDRH director Jeff Shuren calls the action a significant milestone, as it “marks the first time a device
Drugs
FDA has cleared a Spirair 510(k) for its SeptAlign system for treating nasal septal deviation (NSD), a “minimally invasive treatment that can be safely and conveniently performed under local anesthesia,” according to the company. “The bioabsorbable SeptAlign implant is inserted in the cartilage near the front of the nose
Drugs
FDA has approved a supplemental BLA submitted by Janssen for Carvykti (ciltacabtagene autoleucel) to treat adults with relapsed or refractory myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide (Celgene’s Revlimid). Carvykti is the
Drugs
FDA has issued Supernus Pharmaceuticals a second complete response letter (CRL) on its NDA resubmission for the company’s apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (“off”episodes) in Parkinson’s disease. The letter said the submission is not ready for approval in its present
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members, excluding consumer and industry representatives, to serve on CDRH’s Patient Engagement Advisory Committee. The agency says nominations received on or before 6/4 will be given first consideration for committee membership To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing a 6/6 public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” The meeting will include presentations from the agency on the five-year plan for user fee programs,
FDA Policy/General
Federal Register notice: FDA determines that 24 listed drug products were not withdrawn from sale for reasons of safety or effectiveness. The determination allows the agency to continue to approve ANDAs that reference a listed products as long as they meet relevant legal and regulatory requirements. To view the notice,
Devices
FDA has granted Onkos Surgical a de novo marketing authorization for its novel antibacterial coated implants. The authorization is based on preclinical safety and efficacy data showing that the “proprietary coating does not elute and has been proven to be bactericidal, with a 99.999% (5 log) kill rate in