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
FDA Policy/General
Federal Register notice: FDA has determined that Indivior’s Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Buprenex
Biologics
FDA has published a final guidance, Covid-19: Developing Drugs and Biological Products for Treatment or Prevention, to assist sponsors in developing such products. The document describes the agency’s current recommendations for Phase 2 and 3 trials, with a focus on trial population, trial design, efficacy endpoints, safety considerations,
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Translation of GLP Study Reports: Questions and Answers.” The document provides information to sponsors and nonclinical laboratories about study reports being translated from the original language into English, and appropriate documentation to ensure accurate and complete study data are
FDA Policy/General
FDA is declining to take the action sought in an 8/3/2020 petition from Knowledge Ecology International to ban all music during the presentation of risk information in direct-to-consumer ads. In its response, the agency says its current approach includes the assessment of background music in ads,
Devices
FDA has cleared a Masimo 510(k) for Masimo W1 medical watch for providing continuous real-time oxygen saturation (SpO2) and pulse rate (PR) for over-the-counter and prescription use. The company says the watch was developed to be lifestyle-friendly to provide users with “untethered continuous pulse oximetry
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,
FDA Policy/General
Federal Register notice: FDA is announcing a public workshop entitled “Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice.” The workshop will discuss aspects of complex adaptive, Bayesian, and other novel clinical trial designs. It may also serve as the basis of a future a
FDA Policy/General
Federal Register notice: FDA is announcing a 1/23/24/2024 public meeting entitled “Advancing Drug Development for the Prevention of Spontaneous Preterm Birth.” The meeting is intended to gather stakeholder input on the impact of preterm birth on families and on society, as well as on the ethical, regulatory,
FDA Policy/General
Federal Register final rule: FDA is issuing a final rule on direct-to-consumer television and radio advertisements for prescription drugs and a requirement that the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner. The rule establishes standards to determine
Devices
FDA has published a draft guidance, Translation of GLP Study Reports: Questions and Answers, with information for sponsors and non-clinical laboratories about the language translation of study reports for studies conducted in compliance with good laboratory practice (GLP) regulations. The document says GLP studies include nonclinical toxicology studies, safety
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
Devices
SoClean has recalled its SoClean2 and SoClean3 equipment that is used to clean, sanitize, or disinfect CPAP sleep apnea devices and accessories. The recall comprises a new User Manual with additional instructions for use and a hose and mask adapter that is intended to help reduce potential health risks of
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
Drugs
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
FDA Policy/General
FDA commissioner Robert Califf says some postmarketing evidence-generating studies are so important that they may need public funding to ensure they get completed. Speaking in a Yahoo! Finance video interview, Califf says he prefers to consider postmarketing evidence-generation as a way of looking forward rather than looking back.
Drugs
Bayer is recalling one lot of Vitrakvi (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles, indicated for treating solid tumors that are NTRK gene fusion positive, due to microbial contamination identified as Penicillium brevicompactum that was detected during routine stability testing. While there are limited data on human
Drugs
A bipartisan group of nine senators led by Sen. Rand Paul (R-KY) is asking FDA for information on the specific steps the agency is taking to update its animal testing regulations and the timeline for the implementation of a revised regulatory framework under the FDA Modernization Act 2.0.
Devices
FDA has approved a Medtronic PMA for its Symplicity Spyral renal denervation system for treating hypertension. The device works by delivering radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. The therapy is administered by catheter in the artery leading to the
Drugs
FDA has delayed a 12/16-expected review decision on a Bristol Myers Squibb and 2seventy bio supplemental BLA for Abecma (idecabtagene vicleucel) and its use in earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM). The agency has elected to seek input from its Oncologic Drugs
FDA Policy/General
Federal Register notice: FDA is announcing a 12/14 public meeting entitled “Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement.” The workshop is intended to focus on how best to understand patients’ experiences living with a rare disease and how to incorporate those experiences, as well as