FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and OHRP.” The document is intended to assist IRBs, sponsors, and investigators in understanding the processes used for reviewing research involving children
Drugs
FDA has released a final guidance entitled “Identification of Medicinal Products — Implementation and Use” that is intended to support the development and implementation of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards for substances, terminologies, and other information for use throughout the global medicinal product development
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Prescription Drug Advertising” (OMB Control Number 0910-0686). The collection supports agency regulations that require manufacturers who advertise prescription drugs/biologics to disclose in their ads certain information about the product’s uses and risks. It is
Drugs
A U.S. government amicus brief has FDA supporting the generic drug industry in a closely watched Supreme Court appeal of a lower court’s ruling in a so-called “skinny label” case brought by GlaxoSmithKline (GSK) against Teva over a generic form of GSK’s heart drug Coreg (carvedilol)
Devices
Datascope has recalled its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps due to a communication loss between the devices’ executive processor printed circuit board assembly (PCBA) and their video generator PCBA which may cause an unexpected shutdown. The shutdown can occur without warnings or alarms to alert the user,
FDA Policy/General
Federal Register notice: FDA has announced a 4/14 joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee. Panel members are scheduled to discuss an Otsuka Pharmaceutical and Lundbeck supplemental NDA for Rexulti (brexpiprazole) tablets for treating agitation associated with Alzheimer’
Devices
FDA says it is evaluating safety concerns with the use of certain dental devices that are fixed (non-removable) palatal expanders and used on adults to remodel the jaw or treat conditions. An agency safety communication says the devices of concern are: * anterior growth guidance appliance and fixed anterior growth
FDA Policy/General
Midwest Veterinary Supply, based in Minnesota, has pleaded guilty to introducing misbranded veterinary drugs into interstate commerce and will pay more than $10 million in criminal fines and forfeiture. A Department of Justice news release says the company supplies prescription drugs for animals to veterinarians, farms, feedlots, and other businesses.
Devices
FDA has published a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, to provide “a forward-thinking approach to promote the development of safe and effective medical devices that use machine learning (ML) models trained by
Devices
Reps. Larry Buschon (R-IN) and Diana DeGette (D-CO) have reintroduced the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, that they say would create a new framework to verify the accuracy of various medical tests that doctors and patients rely on to make important health decisions. In a
Drugs
FDA has published a guidance, Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and OHRP, to assist institutional review boards (IRBs), institutions, investigators, and sponsors in understanding the processes used for review of research involving children as subjects that is not
Biologics
CBER director Peter Marks says he hopes to align global regulations to boost commercialization for gene and cell therapies so more treatments are launched for patients with rare diseases. Marks spoke on 3/29 at the Reuters Pharma USA conference. Health regulators including FDA and the European Medicines Agency have
Devices
FDA has approved an Abbott PMA supplement for Epic Max, a stented tissue valve to treat people with aortic regurgitation or stenosis. The device is the latest addition to Abbott’s Epic surgical valve platform. Such valves are recommended for patients requiring valve replacement who aren’t suitable for blood
Drugs
FDA has converted from accelerated to full approval Merck’s Keytruda (pembrolizumab) to treat certain adult and pediatric patients with advanced microsatellite instability-high or mismatch repair deficient solid tumors. The full approval is for treating adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair
FDA Policy/General
FDA commissioner Robert Califf says that proposed budget cuts of up to 22% being floated by Republican lawmakers would have a devasting effect on the agency and the industries it serves. Testifying at a 3/29 House Appropriations Subcommittee hearing, Califf was asked by ranking member Sanford Bishop (D-GA)
Drugs
FDA has lifted its partial clinical hold against Vigil Neuroscience and doses greater than 20 mg/kg for VGL101 in clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). The investigational drug is currently being studied in IGNITE, a Phase 2 proof-of-concept
FDA Policy/General
Federal Register notice: FDA has announced a 5/9 joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee. Panel members are scheduled to discuss a Laboratoire HRA Pharma supplemental NDA for Opill (norgestrel), indicated for nonprescription use as a once-daily oral
FDA Policy/General
Federal Register notice: FDA has announced a 5/11 Pulmonary-Allergy Drugs Advisory Committee meeting to discuss an ARS Pharmaceuticals NDA for epinephrine nasal spray, indicated for emergency treatment of allergic reactions (Type I) including anaphylaxis in adults and children. To view the notice, click here.
Devices
An FDA guidance, Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act, says the agency does not intend to issue “refuse to accept” decisions for premarket submissions submitted for cyber devices before 10/1 based solely on the information
Drugs
A 6/23/22-7/8/22 FDA inspection of two pediatric clinical trials conducted by Dr. Robert Hayashi at the Washington University School of Medicine in St. Louis, MO, found objectionable conditions that indicated Hayashi did not adhere to the applicable legal requirements and regulations governing the conduct of
Devices
Artificial Intelligence/Machine Learning (AI/ML) regulatory principles are in greater flux and progressing at a greater rate than any other area of FDA regulatory oversight. That’s the view of attorney Jesse Atkins (Gardner Law) in an online post. “In a discipline as dynamic as this,” he writes, “the
Drugs
FDA and the Lupus Research Alliance have launched the Lupus Accelerating Breakthrough Consortium (Lupus ABC) focused on addressing challenges affecting lupus clinical trial success. An agency announcement says Lupus ABC “will convene people living with lupus, medical societies, industry, academic clinical researchers and scientists, FDA, and other federal agencies to