Drugs
FDA has released a 28-page FDA-483 with 13 observations from a 9/20-11/30/21 inspection at Edge Pharma, a Colchester, VT, outsourcing facility. The inspection observations were: * buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good
Biologics
Sanofi and GlaxoSmithKline say they will submit data to FDA supporting their request for regulatory authorization for a Covid-19 vaccine. The companies say that in a Phase 3 trial, two doses of the vaccine demonstrated 100% efficacy against severe Covid-19 disease and hospitalizations, 75% efficacy against moderate or
Drugs
AbbVie has submitted a supplemental NDA for Vraylar (cariprazine) for the adjunctive treatment of major depressive disorder in patients who are receiving ongoing antidepressant therapy. The submission is based on data from a Phase 3 study that showed a clinically and statistically significant change from baseline to week six in
FDA Policy/General
Federal Register notice: FDA is publishing a proposed rule to amend medical device current GMP requirements of the Quality System Regulation to align more closely with the International Organization for Standardization’s 13485. It is also proposing additional requirements to clarify device GMP requirements for combination products. To view the
Drugs
FDA says it intends to engage in notice-and-comment rulemaking on statutory provisions about certain distributions of compounded human drugs and a standard memorandum of understanding (MOU) between the agency and states. An online notice says the need for rulemaking came in 10/2020 when FDA was sued in
Devices
Medtronic says it appreciates FDA efforts to establish appropriate considerations for premarket submissions for medical devices with physiologic closed-loop control technology. Commenting on the agency’s 12/23/21 draft guidance on the topic, the company says it also appreciates the agency’s recognition of the value of computational
Devices
FDA has granted Noninvasix a breakthrough device designation for its LivOx Central Venous Oxygenation Monitor for real-time, continuous or spot monitoring of central venous oxygen saturation (ScvO2) in adults at risk of septic shock. “Measuring ScvO2 non-invasively will open new paths to more efficient and earlier diagnosis of
Drugs
CDER has announced a 4/13 Webinar entitled “Biosimilars: A Decade of Experience and Future Directions—Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology.” The program is being presented by CDER’s Office of Clinical Pharmacology and the University of Maryland’s Center of Excellence in
Devices
Baxter International has issued an urgent safety communication to highlight important information on the device’s upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps. “Incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms may result in reduced delivery or non-delivery of medication,
Drugs
Ferring Pharmaceuticals is asking FDA to put restrictions on any section 505(j) ANDA and 505(b)(2) NDA citing the company’s Firmagon (degarelix acetate) for subcutaneous injection to treat patients with advanced prostate cancer. In a 2/9 petition, Ferring asks for a determination that any generic ANDA
Devices
FDA has classified as Class 1 a recall of the E25Bio Covid-19 Direct Antigen Rapid Test. “This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by
Drugs
FDA says its approval of a generic diclofenac sodium topical gel 1% was the first ANDA approval for which a physiologically based pharmacokinetic (PBPK) model supported the bioequivalence assessment. An agency paper says CDER researchers have been investigating how pharmacokinetic modeling can support a bioequivalence determination for topical drug products.
Drugs
What is believed to be the first reported survey on views of the U.S. public on FDA transparency shows that the public would like to see much more transparency from the agency. Researchers from Johns Hopkins University write in a JAMA open access article that they asked a representative
Drugs
Former CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger has joined Hyman, Phelps & McNamara as a principal drug regulatory expert. After 24 years at FDA, Unger retired from the agency last year to spend more time with family. He joined FDA in 1997 as a medical
Devices
FDA is proposing to incorporate by reference in the Quality Management System the International Organization for Standardization ISO 13485, approved in 2016. A Federal Register notice says FDA has historically recognized the benefits of harmonization with other regulatory authorities and over time has acted to promote consistency with its regulatory
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a 9/22/21 video interview with the then-CEO of CytoDyn, Vancouver, WA, represented in a promotional context that leronlimab, an investigational new drug, is safe and effective for the purpose for which it is being investigated. Specifically, according to
Drugs
An 8/13-9/14/21 FDA inspection at Toxikon/Labcorp Bedford, Bedford, MA, conducted under the agency’s Bioresearch Monitoring Program, found violations of the Good Laboratory Practice regulations. A 2/10 Warning Letter says specific violations were: * failure of the study director to assure that all experimental data,
Devices
FDA says the 1/20 recall by BASE10 Genetics of its RNAstill MTM specimen collection kits is Class 1. The company is recalling the kits because they were distributed without proper premarket clearance from FDA. An agency notice says there are not enough data available about the product to know
Drugs
A Natural Products Association petition to FDA asks the agency to stop excluding hemp-derived cannabidiol (CBD) from the definition of a dietary supplement. A Nutritional Outlook online post (includes a link to the petition) says the trade group specifically asks that FDA: * determine CBD is not excluded from the
FDA Policy/General
More Product-specific Guidances for ANDAs 2/18/2022 Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances that provide recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here. Info Collection Extension on CDRH Appeals Processes
FDA Policy/General
Palatin Technologies has entered into a collaboration and license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co. to develop and commercialize bremelanotide for female sexual dysfunction (FSD) indications. Bremelanotide is an investigational product designed for on-demand treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. Under the agreement,
FDA Policy/General
DEVICES FDA has approved a CeloNova Biosciences PMA for its COBRA PzF NanoCoated Coronary Stent System. The device, which is coated with a biocompatible proprietary nanothin polymer, requires a minimum 30-day dual antiplatelet therapy regimen after intervention, according to the company. The stent is designed to improve coronary luminal