Drugs
A 10/18-11/17/22 FDA inspection at the Omega Packaging Corp. drug manufacturing facility in Totowa, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/20 Warning Letter says specific violations were: * failing to test samples of each component for identity
Devices
Researchers from the University of Missouri-Kansas City and other facilities say post-approval modifications to Class 3 medical devices approved through the premarket approval (PMA) supplement process are associated with an increased risk of device recall. The study, published by JAMA Network Open, says an “increase of one supplement
Drugs
Vanda Pharmaceuticals says FDA should revoke its approval of a Teva ANDA for a generic form of Vanda’s Hetlioz (tasimelteon 20 mg capsules), indicated to treat non-24-hour sleep/wake disorder, and order the product recalled because it fails to satisfy the bioequivalence requirement. A Vanda 4/10
Drugs
FDA has published a draft guidance, Assessing the Irritation and Sensitization Potential of Generic Transdermal and Topical Delivery Systems for ANDAs, with recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed drug transdermal or topical delivery
Drugs
An antiabortion group leading the legal fight against the abortion drug mifepristone (Mifeprex) told the Fifth Circuit Court of Appeals 4/11 that the court does not have jurisdiction to review the lower court’s order because that was an administrative stay and not a preliminary injunction, but the Department
Devices
An FDA safety alert is recommending against the use of certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks manufactured by the company. Laboratory test results show certain models of O&M Halyard surgical N95 respirators,
Drugs
FDA has cleared an Avation Medical 510(k) for Vivally, which the company describes as a non-invasive, bladder control therapy device and mobile application for treating patients with urinary urgency and urge urinary incontinence caused by overactive bladder syndrome. The “closed loop” neuromodulation system “objectively confirms activation of the
Drugs
FDA has released a draft guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers” that contains recommendations on monitoring studies involving drugs, biologics and medical devices. It provides input on planning a monitoring approach, developing the monitoring plans content, and communicating monitoring results. The document
Drugs
FDA has placed a partial clinical hold on a Molecular Templates (MTEM) Phase 1 study of MT-0169 based on previously disclosed cardiac adverse events noted in two patients dosed at 50 mcg/kg that prompted a dose reduction from 50 mcg/kg to 5 mcg/kg last year, according
Drugs
Five stakeholders are making suggestions they say will improve the Biosimilar Regulatory Research Pilot Program Roadmap issued as part of the third biosimilars user fee (BsUFA 3) reauthorization. Sandoz says it is a “strong supporter” of the regulatory research on biosimilars outlined in BsUFA 3. It expresses an “overarching concern”
Drugs
An FDA review of records submitted by Champaklal Maganlal Homeo Pharmacy Private Limited, a manufacturer of over-the-counter and homeopathic drug products in Ahmedabad, Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/10 Warning Letter says the specific violation was
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that while it supports the general development of the International Council for Harmonization M13A draft guidance on bioequivalence for immediate-release solid oral dosage forms, it sees several opportunities to improve the draft. The PhRMA comment letter suggests ways to clarify the
Drugs
The FDA Guidance Snapshot Pilot Program, a joint effort of the CDER Office of Translational Sciences (OTS) and the CDER Office of Communications (OCOMM), will soon expand with the issuance of its first two snapshots and podcasts for patients. The program is explained in an online post featuring interviews with
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Generic Drug User Fee Program; Controlled Correspondence.” The collection is being revised to include recommendations found in agency guidance that discusses the process by which generic drug manufacturers and related industry or their representatives can request information
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Medical Devices; Reports of Corrections and Removals — 21 CFR Part 806.” The collection supports an agency regulation requiring device manufacturers and importers to promptly report certain actions concerning device corrections and removals and to maintain associated records.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Investigational New Drug Application Requirements.” The collection is being revised to include burden that may be associated with recommendations found in the guidance document entitled “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (March
FDA Policy/General
Life expectancy in the U.S. is three to five years lower than the average in other high-income countries and one reason is the extent of health misinformation. That’s the view of FDA commissioner Robert Califf, presented in a wide-ranging interview with CNBC. “It’s looking worse,
Devices
Attorneys Dominick DiSabatino and Audrey Crowell (Sheppard Mullin) say a recent FDA guidance and FAQ document explain new medical device cybersecurity safeguard requirements from the Consolidated Appropriations Act of 2023. The attorneys cover which submissions are subject to the new cybersecurity requirements, what the new requirements are, and how the
Devices
A hard-hitting SC Media online post says even the most equipped health systems are unprepared to meet FDA’s new medical device cybersecurity safeguards. The post looks at FDA guidance to implement new requirements from the Consolidated Appropriations Act of 2023 and the six-month grace period given until
Devices
FDA has announced a voluntary Radiation Sterilization Master File Pilot Program to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach. A notice says the pilot will be open to nine companies that sterilize single-use, PMA-
Devices
CDRH director Jeff Shuren acknowledged that new regulatory reforms from Congress will be needed for FDA and the medical device industry to experience transformative outcomes from the quickly developing artificial intelligence (AI) and software-driven medical device space. Speaking at an American Enterprise Institute panel on the future of AI,
Drugs
[Analysis by Jim Dickinson] He “does not second-guess FDA’s decision-making lightly,” writes mifepristone (Mifeprex) trial pro-life judge Matthew J. Kacsmaryk, a Trump appointee, in his 67-page condemnation of the abortion drug – but he relishes doing so. The historic order, the heaviest-ever to hit the