Devices
FDA says the Imperative Care 8/18 recall of specific lots of its ZOOM 71 reperfusion catheter due to the risk of breaks during use is Class 1. The company recalled 3,098 devices distributed in the U.S. between 9/23/20 and 8/9/21. Imperative Care says
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Medical Device Labeling Regulations” (OMB Control No. 0910-0485). The collection supports medical device labeling requirements governed by section 502 of the Federal Food, Drug, and Cosmetic Act. Device labeling requirements provide for the label or labeling
Drugs
FDA has granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center Oncology Knowledge Base as the first tumor mutation database to be included in the Public Human Genetic Variant Databases. An agency announcement says FDA recognized a portion of the database as a source of valid
FDA Policy/General
The Biden Administration is nearing its choice of a nominee for FDA commissioner. Addressing reporters on 10/5, president Biden was asked whether he had chosen someone for the agency‘s top job. “We’ll be talking about that in a little bit,” he responded. The Biden Administration reportedly has
Drugs
Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) have introduced the FDA Modernization Act to end animal testing mandates. Kentucky’s ABC36 TV news says the bill “would end an outdated FDA mandate that experimental drugs must be tested on animals before they are used on humans in
FDA Policy/General
Immunicom has named Christian Shenouda, who worked at FDA in both CDER and CDRH, as vice president of regulatory affairs to develop and execute a regulatory strategy to integrate its Immunopheresis therapy into standard medical practice. A company statement says Immunicom “expects streamlined regulatory approval for the Immunopheresis therapy under
Drugs
FDA has placed a clinical hold on Allogene Therapeutics clinical trials involving Allo-501A CAR T cells after a report of a chromosomal abnormality in the company’s ALPHA2 study. The abnormality, which was detected in a bone marrow biopsy undertaken to assess pancytopenia (low blood counts), was reported to
Biologics
Pfizer and BioNTech say they have formally submitted an emergency use authorization request to permit use of their mRNA Covid-19 vaccine in children aged 5 to under 12 years of age. Last week, the companies submitted FDA Phase 2/3 clinical trial data that they said demonstrated a favorable
Devices
FDA has issued a final order reclassifying surgical staplers for internal use from Class 1 (general controls) to Class 2 (special controls) and requiring them to undergo premarket review. An agency statement says that as a result of the order, surgical staplers for internal use “will be subject to more
Drugs
NeuroMetrix has filed a de novo request for its Quell wearable neuromodulation device for treating symptoms of fibromyalgia in adults. The company received an FDA breakthrough designation for this indication in July. The submission is based on data from a double-blind, randomized, sham-controlled trial (NCT03714425) involving 119 patients
Drugs
FDA has published a draft guidance, Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, describing how the agency will apply certain provisions of Section 503A of the Federal Food, Drug, and Cosmetic Act (FFDCA) to human drug products that are compounded by
Drugs
FDA has issued a complete response letter declining to approve in its current form a Polarean Imaging NDA for an investigational drug-device combination product using hyperpolarized xenon-129 gas to enhance MRI imaging in pulmonary medicine. The company says the letter was “unexpected” and contained issues that are “mostly
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs. The document describes FDA’s current thinking on incorporating real-world data and real-world evidence (including ongoing surveillance activities, observational studies,
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs. The document addresses incorporating data from foreign countries into proposed clinical investigational protocols and applications for new animal drugs. to view the notice, click
Drugs
Cassava Sciences says it has started an initial Phase 3 efficacy study of simufilam, its investigational drug for patients with Alzheimer’s disease. A second Phase 3 efficacy study is expected to launch before the end of 2021, the company says. The company announcement says the studies are being conducted
Drugs
Three Faegre Drinker consultants say an FDA September draft guidance on benefit/risk assessments for drugs and biological products “is an important step in increasing transparency of the FDA decision-making process. It gives sponsors, patient advocacy organizations, and other stakeholders a view into how FDA is using the relatively
Drugs
FDA has accepted for review an Acer Therapeutics NDA for Acer-001 (sodium phenylbutyrate) for treating patients with urea cycle disorders (UCDs). Acer says the submission is based on data from two bioequivalence trials in which Acer-001 showed similar relative bioavailability compared to the reference drug, Ucyclyd Pharma’s
Drugs
FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation are sponsoring a two-day virtual public workshop on “Fetal Pharmacology and Therapeutics” on 10/21-10/22. An announcement says the workshop will discuss the current state of fetal pharmacology and therapeutics and how it
Drugs
FDA has published a draft S1B addendum to the International Council for Harmonization (ICH) S1 guidances and documents on the need for carcinogenicity studies for pharmaceuticals. The ICH says the addendum expands the testing scheme for assessing the human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach
Drugs
FDA says its 3/9-3/16/20 inspection at Walter Corp., doing business as The Medicine Shoppe, Port Charlotte, FL, found that drugs the company produces failed to meet the conditions of Section 503A of the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition, a 9/17 Warning
Drugs
The FDA Antimicrobial Drugs Advisory Committee meets 10/7 to consider Takeda’s maribavir to treat cytomegalovirus (CMV) infection in the post-transplant setting. An agency briefing paper distributed in advance of the meeting says Takeda submitted a Phase 2 and Phase 3 trial evaluating the efficacy of maribavir for
Drugs
An unexpected safety signal has led Takeda Pharmaceutical Co. to halt two Phase 2 studies of TAK-994, an investigational oral orexin agonist for treating narcolepsy. Without providing any details of the safety concern, Takeda says that stopping the trials “allows for the timely interpretation of the benefit/risk profile