FDA Policy/General
Federal Register notice: FDA is seeking public comments on an information collection extension associated with its “Guidance for Industry and FDA Staff — Class 2 Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle” (OMB Control Number 0910–0594)— Extension. The collection is authorized
FDA Policy/General
Federal Register notice: FDA has determined that Arbor Pharmaceuticals’ Nymalize (nimodipine) oral solution was not withdrawn from sale due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs for this reference product if all other legal and regulatory requirements are met. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has announced a 4/15 meeting of its Cellular, Tissue and Gene Therapies Advisory Committee. The panel is scheduled to discuss a CellTrans BLA for donislecel (purified allogeneic deceased donor pancreas derived islets of Langerhans), indicated for treating brittle Type 1 diabetes mellitus. The morning session
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
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
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
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
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.
FDA Policy/General
A provision in a budget reconciliation bill moving its way through the U.S. House of Representatives would provide FDA with a $500 million boost for Covid-19 activities. On 2/11, the House Energy and Commerce Committee considered portions of the bill, which will next be consolidated with reconciliation
FDA Policy/General
Some 94 oncology physicians, researchers, and leaders have signed a 2/11 letter to President Joseph Biden urging the selection of FDA acting commissioner Janet Woodcock to be the agency’s next commissioner. Those signing the letter include some who served on Biden’s Cancer Moonshot Blue Ribbon Panel when
FDA Policy/General
Federal Register notice: FDA has announced a 2/26 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to review and discuss a Janssen Biotech emergency use authorization application for an investigational vaccine to prevent Covid-19. To view the notice, click here.
FDA Policy/General
An analysis of CDER Office of Prescription Drug Promotion (OPDP) enforcement actions in 2020 by Eye on FDA found the same pace as in recent years, what the online publication calls “anemic levels of enforcement.” The post says the six regulatory letters were exclusively aimed at smaller, less experienced companies.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Allay Pharmaceuticals, Hialeah, FL (1/27) FDA inspected the firm 5/2020 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written
FDA Policy/General
FDA says it has created a Web page listing clinical field studies that are investigating animal cells, tissues, and cell- and tissue-based products (ACTPs) in veterinary patients. “The Web page provides animal owners, veterinarians, researchers, and the public with information on clinical field studies that are being investigated for
FDA Policy/General
FDA says it is developing guidances for developers of Covid-19 diagnostics, therapeutics and vaccines to help guide their need to adapt and pivot as new variants of coronavirus (Covid-19) are identified. “We have been actively assessing the impact of new strains on authorized products and continue to work
FDA Policy/General
An LA Times op-ed is endorsing CDER director and current FDA acting commissioner Janet Woodcock as the agency’s next leader. The piece was written by Massachusetts Institute of Technology professor Phillip A. Sharp, Friends of Cancer Research founder Ellen V. Sigal, and Sherry Lansing Foundation founder Sherry Lansing.
FDA Policy/General
Pharmaceutical consulting firm Indegene says doctors are expressing discontent with elements of the virtual drug detailing forced by the pandemic, although they also are not very pleased with in-person detailing. In an online white paper, Indegene reports that one in three healthcare professionals is dissatisfied with contacts with drug
FDA Policy/General
The Government Accountability Office (GAO) says FDA and many other HHS agencies should be doing more as part of the government’s response to the Covid-19 pandemic. GAO also criticizes the agencies for not implementing many of its earlier recommendations. In its latest report, GAO says FDA should: * as