Biologics
Special Counsel Henry Kerner says he agrees with an assertion by former FDA consumer safety officer Arie Menachem that the agency narrowly focused on procedural issues in its response downplaying Menachem’s whistleblower complaints and “disregards the fact that inspection reports detailing serious concerns were downgraded in a manner that
Devices
FDA says the Medical Device Innovation Consortium is seeking medical device manufacturers to participate in an Accelerate Sustainable Capability (ASC) pilot study that was developed in collaboration with the medical device industry, Information Systems Audit and Control Association, and FDA. An agency notice says the pilot study is intended to
FDA Policy/General
Federal Register notice: FDA is amending its medical device regulations to make an editorial nonsubstantive change and replace a reference to an obsolete office with updated information. The regulations specified in the notice have been revised to correct “director of the Office of Regulatory Program” to “director or Principal Deputy
FDA Policy/General
Federal Register notice: FDA has announced a 5/27 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss the safety and efficacy of a Provention Bio BLA for teplizumab intravenous infusion, indicated for the delay or prevention of clinical Type 1 diabetes mellitus in at-risk
FDA Policy/General
Federal Register notice: FDA has announced a 5/26-27 workshop entitled “FDA Science Forum 2021.” The workshop will discuss FDA research, including: (1) improving clinical and postmarket evaluation; (2) substance use, misuse, and addiction; (3) product development and manufacturing; and (4) medical countermeasures, infectious disease, and pathogen-reduction technologies.
FDA Policy/General
Federal Register notice: FDA is amending its electronic import entries regulation to correct the statutory citation in the sections of that regulation requiring submission of the Drug Registration Number for human drugs and for animal drugs. The revisions are necessary to correct editorial errors and to ensure that the codified
Devices
CDRH director Jeffrey Shuren says the FDA Medical Device Development Tools (MDDT) program is a way for the agency to qualify tools that medical device developers can use in the development and evaluation of medical devices. Writing in an online FDA Voices post, Shuren says qualification means the agency has
Drugs
Three academics from different universities who participated in the 11/6/20 meeting of the FDA Peripheral and Central Nervous System Drugs Advisory Committee that considered the efficacy and safety of Biogen’s aducanumab for use in treating Alzheimer’s disease say that randomized trials should remain the primary means
Drugs
FDA says its review of study findings showed a potential increased risk of heart arrhythmias in patients with heart disease who are taking the seizure and mental health medicine lamotrigine (GlaxoSmithKline’s Lamictal and generics). An agency drug safety communication says FDA wants to evaluate whether other medicines in the
Devices
An FDA safety communication is cautioning patients, caregivers, and healthcare providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction have a higher chance of complications or problems. The online communication says the agency has not cleared or approved ADM or mesh for use in breast
Drugs
FDA has approved a new indication for Jazz Pharmaceuticals’ Vyxeos (daunorubicin and cytarabine) to treat newly-diagnosed therapy-related acute myeloid leukemia with myelodysplasia-related changes in pediatric patients aged one year and older. A company statement says approval of the new indication was supported by safety data from two
Biologics
Evive Biotech has submitted a BLA for Ryzneuta (also known as F-627), indicated for treating chemotherapy-induced neutropenia. Neutropenia is a common chemo side-effect that is characterized by low levels of neutrophils, a type of white blood cell that fights infection, according to the company. It says Ryzneuta
Devices
The leader of a Facebook group involving patients injured by LASIK eye correction procedures is urging FDA acting commissioner Janet Woodcock to crack down on false and misleading advertising by LASIK providers. Paula Cofer, who founded the 7,400-member LASIK Complications Facebook Group in 2014 to give a voice
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: PYRLess Group, Amarillo, TX (2/25): FDA has reviewed the firm’s Web sites (https://drfitt.com and https://drfittinfo.com) and
Devices
FDA has cleared a Nines 510(k) for the NinesMeasure, a lung nodule measurement tool built with artificial intelligence that is intended to accelerate diagnoses of certain respiratory diseases. The company says the device enables radiologists to quickly measure the long and short axes of selected nodules with a high
Drugs
A 9/9-9/27/19 FDA inspection at Tarmac Products, Miami Gardens, FL, found multiple violations in the firm’s manufacturing of over-the-counter drug products and wound dressing medical devices. A just-released 11/9/20 Warning Letter lists violations of current good manufacturing practice (CGMP) regulations
Drugs
The Biotechnology Innovation Organization (BIO) says it encourages FDA to include case study examples in an upcoming public workshop on best practices for the development and application of disease progression models. In a comment letter, BIO says its members are willing to offer case study examples for inclusion in meeting
Drugs
FDA has accepted for review an AbbVie NDA for atogepant, an orally administered calcitonin gene-related peptide receptor antagonist for the preventive treatment of migraine in adults who meet criteria for episodic migraine. The company says it expects a regulatory decision late in the third quarter. The submission is based
Biologics
FDA has approved for clinical trials an experimental treatment using a CRISPR-based therapy to directly correct the mutation in the beta-globin gene responsible for sickle cell disease. The technique was developed at the Innovative Genome Institute, a joint research collaboration of the University of California, Berkeley, and the
Biologics
Panelists at the recent Festival of Biologics USA conference debated the worth of clinical efficacy studies for evaluating biosimilar equivalence. A Center for Biosimilars online post says that while many experts have said the clinical studies are not sensitive enough in comparison with other tests to provide convincing evidence of
Drugs
Akebia Therapeutics has submitted an NDA for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating anemia due to chronic kidney disease in adult patients on or not on dialysis. The submission was prepared in collaboration with Otsuka Pharmaceutical. It includes data from over 8,000 patients
FDA Policy/General
HHS has published its semiannual regulatory agenda for all agencies within the department. The listing for FDA covers six items in the final rule stage and four completed actions.