FDA Policy/General
A white paper called “What Needs to Change at the FDA” says the agency’s evidence standards have become distorted, which have led to decisions that often favor industry interests over those of the public, and an “anecdotal ideology among FDA senior management that patients are willing to accept more
Devices
FDA has approved expanded labeling on Medtronic’s SelectSecure MRI SureScan Model 3830 cardiac lead for conduction system pacing, which the company says “taps into the heart’s natural electrical system, giving patients needed therapy while avoiding complications sometimes associated with traditional pacing methods, such as cardiomyopathy.” The company says
Drugs
Responding to an upcoming FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting to discuss CDER’s Quality Management Maturity (QMM) and Knowledge-Aided Assessment and Structured Application (KASA) programs, Pharmaceutical Research and Manufacturers of America (PhRMA) says it has issues that it would like to be considered by the
Drugs
FDA has published a guidance, Multiple Endpoints in Clinical Trials, presenting the agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how they can be managed in clinical trials for human drugs and biologics. The document says that when more
Drugs
Talaris Therapeutics says it learned on 10/18 of the death of a subject enrolled in its FREEDOM-1 Phase 3 trial of FCR001 in living donor kidney transplant patients. A company statement says the subject was one of three reported in June to have been diagnosed with grade 2
Drugs
FDA has released the form FDA-483 with two observations from a 7/26-8/5 inspection at ImClone Systems, Branchburg, NJ, a drug substance manufacturer. The inspection observations were: * failing to control the disposition and availability of drug substances determined to be within the scope of deviation investigations before
Devices
University of Michigan professor Kevin Fu, who was the CDRH acting director of medical device cybersecurity, says companies don’t have to wait for FDA to finalize its guidance before starting to develop and submit software bills of materials (SBOM). In an interview posted in a ReversingLabs blog, Fu says
Drugs
A recent inspection at Hikma Injectables USA (Dayton, OH) has led to a three-item Form FDA-483. For example, agency investigators cited the firm’s aseptic processing areas because they did not have adequate monitoring of environmental conditions. The agency also said Hikma’s aseptic processing areas were “deficient
Devices
FDA has published a draft guidance, Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare, to propose select updates to the Breakthrough Devices Program guidance. The document says the existing guidance remains in use in its current form until this draft is finalized. “FDA intends
Devices
FDA has closed its post-approval study requirements for Abiomed PMA for its Impella heart pumps. As a result, the company says the agency has affirmed that the pumps are safe and effective for cardiogenic shock, high-risk percutaneous coronary intervention (PCI), post-cardiotomy cardiogenic shock, cardiogenic shock in the
Drugs
FDA says it is launching its Advancing Real-World Evidence (RWE) Program to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims, including approval of new indications for approved medical products or to satisfy post-approval study requirements. An agency notice says the
Drugs
PTC Therapeutics says enrollment in its Phase 2 PIVOT-HD trial of PTC518 to treat Huntingdon’s disease has been paused in the U.S. due to an FDA request for additional data to allow the study to proceed. A company statement says trial enrollment “is active and ongoing” in
Devices
FDA says the Philips Respironics 8/2 recall of 18,670,643 select masks for BiPAP and CPAP machines is Class 1. Philips says the devices were distributed between 1/1/2015 and 9/9/2022. An FDA notice says they were recalled due to a “serious safety concern” involving
Devices
FDA is reminding the medical device industry and unique device identifier (UDI) stakeholders that the 5/2021 guidance on enforcement policy regarding the use of National Health Related Item Code and National Drug Code numbers on device labels and packages applies only to devices labeled before 9/24/23. An
Drugs
FDA’s Obstetrics Reproductive and Urologic Drugs Advisory Committee10/19 voted 14 to 1 to recommend the market withdrawal of Covis’ Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly) because data show the accelerated-approval drug is not effective. It was approved in 2011 for reducing the risk of
Biologics
FDA has announced five research grants made under the Biosimilar User Fee Act (BsUFA) research grant program in the areas of (1) improving the efficiency of biosimilar product development and (2) advancing the development of interchangeable products. The five grants are: * assessment of the performance of multi-attribute method versus
Drugs
FDA has released the form FDA-483 issued following a 9/19-9/28 inspection at Torrent Pharmaceuticals, Indrad, Gujarat, India, a finished product and active pharmaceutical ingredient manufacturer. The three inspection observations were: * equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would
Drugs
The latest HDA Research Foundation “Serialization Readiness Survey” says there continues to be uneven readiness as supply chain partners prepare for the 2023 Drug Supply Chain Security Act (DSCSA) implementation milestone. “FDA’s granting of enforcement discretion in 2020 until 2023 for certain wholesale distributor and dispenser requirements, while very
Drugs
Two women who worked for Tellus Clinical Research in Miami, FL, have been sentenced by a Florida federal judge to terms in prison for their part in a conspiracy to falsify clinical trial data. A Justice Department statement says Analay Rico, Fort Lauderdale, a lead study coordinator, was sentenced to
Biologics
FDA has granted Novavax an emergency use authorization for its Novavax Covid‑19 Vaccine, Adjuvanted as a first booster dose (0.5 mL) for certain individuals at least six months after completing their primary vaccination with an authorized or approved Covid-19 vaccine. According to the agency, the booster is
FDA Policy/General
After 32 years at FDA, Center for Veterinary Medicine director Steven Solomon is retiring at the end of the year. He began his career at the agency as a veterinary medical officer in the Division of Surveillance and Compliance, according to an email from commissioner Robert Califf. He then moved
Devices
A 3/28-4/4 FDA inspection at Forcemech International, Pearland, TX, determined that the firm is a manufacturer (repackager/relabeler) and initial distributor/importer of the Forcemech Navigator and Navigator XL powered wheelchairs. A 9/21 Warning Letter says the devices are adulterated due to Quality System Regulation violations.