FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Evolved Ayurvedic Discoveries, Encinitas, CA (2/11): FDA reviewed the company’s Web site, Facebook and Instagram pages and determined that the company takes orders for several BioCBD+ products
Devices
FDA has approved a Shockwave Medical PMA for its Intravascular Lithotripsy (IVL) to treat severely calcified coronary artery disease. The sonic pressure wave therapy is intended to pass through soft arterial tissue to disrupt calcified plaque by creating a series of micro-fractures. “After the calcium has been cracked, the
FDA Policy/General
Federal Register notice: FDA has announced a 3/24 joint meeting of the Arthritis and the Drug Safety and Risk Management Advisory Committees. Panel members are scheduled to discuss a Pfizer BLA for tanezumab subcutaneous injection, indicated for relieving signs and symptoms of moderate to severe osteoarthritis in adult patients
FDA Policy/General
Federal Register notice: FDA has announced a 3/5 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 influenza season. To view the notice,
FDA Policy/General
Federal Register notice: FDA has announced a 3/23 meeting of the Medical Devices Advisory Committee’s General and Plastic Surgery Devices Panel. The panel is scheduled to discuss and make recommendations about the benefits and risks of dermal fillers concerning the following topics: (1) Risks associated with intravascular injection
Drugs
An FDA 2020 review of the Web site and Facebook and Instagram pages maintained by Evolved Ayurvedic Discoveries, Encinitas, CA, determined that the company takes orders for several BioCBD+ products that claim to contain cannabidiol. A 2/11 Warning Letter says the Web site offers products that are intended to
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a banner ad and tabletop display for AcelRx’ Dsuvia (sufentanil) sublingual tablets make false or misleading claims and representations about the drug’s risks and efficacy. A 2/11 Warning Letter says oral opioids such as Dsuvia include risks for accidental
Drugs
FDA has approved an expanded indication for Novartis’ Entresto (sacubitril/valsartan) to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. The approval notes that benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. The
FDA Policy/General
A lengthy article in The Hill details how former FDA commissioner Stephen Hahn got help from a group of outside scientists, known informally as his “kitchen cabinet,” to withstand political pressures on the agency from the Trump administration. Hahn, an oncologist with no experience running a government agency, took over
Devices
CDRH director Jeffrey Shuren and Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel say that knowing what they know now, they would not have permitted SARS-CoV-2 serology tests to be marketed without FDA review and authorization. Writing in a New England Journal of Medicine Perspective,
Devices
An FDA briefing document released in advance of a 2/17 meeting of the Cardiovascular Devices Panel that will consider a PMA application submitted by Lutonix for its 014 drug-coated balloon PTA (percutaneous transluminal angioplasty) catheter says that limitations associated with the primary and supplementary data in the application
Biologics
FDA has approved a Pfizer supplemental BLA for Panzyga (immune globulin intravenous [human] – ifas 10% liquid preparation) to treat adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a rare peripheral nerve neurological disease. Approval was based on data from a Phase 3 study in 142 patients diagnosed with CIDP. The
Biologics
Bluebird Bio has temporarily suspended its Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease due to a reported “suspected unexpected serious adverse reaction” (SUSAR) of acute myeloid leukemia (AML). The company says it received a report last week that
Devices
FDA and Defense Advanced Research Projects Agency staffers said at a recent Silicon Flatiron event that hardware security and trust must involve the integration of hardware and software protection strategies, as well as resilient build practices. FDA cybersecurity policy advisor Jessica Wilkerson said the growing integration of hardware and software
FDA Policy/General
Joint Panel to Review Pfizer Osteoarthritis BLA Federal Register notice: FDA has announced a 3/24 joint meeting of the Arthritis and the Drug Safety and Risk Management Advisory Committees. Panel members are scheduled to discuss a Pfizer BLA for tanezumab subcutaneous injection, indicated for relieving signs and symptoms of
FDA Policy/General
Catalent Pharma Solutions has broken ground on a $34 million extension to its Madison, WI biologics manufacturing facility. When completed, the additional 22,000 square feet of space will accommodate two 2,000 liter single-use bioreactor systems, allowing the company to support late-phase clinical and commercial production of
FDA Policy/General
FDA has issued a revised final guidance entitled “Investigational Covid-19 Convalescent Plasma.” The agency has revised the recommendations in the guidance addressing convalescent plasma donors. The revisions discuss when individuals who have received an investigational Covid-19 monoclonal antibody therapy as a participant in a clinical trial, or received
Drugs
FDA has announced a 3/23 virtual public workshop entitled “Roadmap to 2030 for New Drug Evaluation in Older Adults” to discuss the current status of including older adults in clinical trials and strategies to ensure safe and effective drug use in the elderly. FDA says it is concerned about
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Application for FDA Approval To Market a New Drug” (OMB Control No. 0910-0001). The revision pertains to provisions established through the agency’s user fee programs, most recently authorized under the FDA Reauthorization Act of 2017.
Drugs
Federal Register notice: FDA has issued a priority review voucher to Alnylam Pharmaceuticals in response to its rare pediatric disease product application for Oxlumo (lumasiran) injection, indicated for treating primary hyperoxaluria Type 1 to lower urinary oxalate levels in pediatric and adult patients. To view the notice, click here.
Devices
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Devices; Device Tracking — 21 CFR Part 821” (OMB Control Number 0910-0442). FDA regulations provide it the authority to require by order that a manufacturer adopt a method for tracking a Class 2 or 3 medical
Biologics
FDA continues to struggle to inspect firms within its user fee application review timelines. The latest company impacted is Mallinckrodt, advised by the agency that action on one of its BLAs is being deferred pending a manufacturing site inspection that can’t be conducted due to Covid-19-related travel