FDA Policy/General
FDA has issued a draft update to guidance for industry #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.” The guidance is intended to help stakeholders assess antimicrobial resistance (AMR) risks in people due to use of medically
FDA Policy/General
The House 12/14 passed S 3905 Preventing Organizational Conflicts of Interest in Federal Acquisition Act that aims to curb government contractors from having conflicted relationships with agencies like FDA and private-sector companies, like pharmaceutical or device companies. The Senate passed the bill in the summer and it now
FDA Policy/General
A new Government Accountability Office report offers recommendations to shield FDA and other HHS agencies from potential political interference, such as converting FDA into an independent agency like the Federal Reserve. GAO said it conducted the review of political interference during the Covid-19 emergency based on allegations it had
FDA Policy/General
A just-published survey has found that clinicians are challenged to interpret results from both Bayesian and traditional statistical outputs from clinical trials. Writing in a 12/10 Therapeutic Innovation & Regulatory Science article, the Drug Information Association’s Bayesian Scientific Working Group, of which FDA is a member, concludes
FDA Policy/General
CVM has released its 2021 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals that shows domestic sales and distribution of medically important antimicrobial drugs for such animals decreased by less than 1% between 2020 and 2021. “Since the significant decrease in sales volume in 2017,
FDA Policy/General
FDA is preparing a manuscript to outline a strategy for getting more diversity into clinical trials, commissioner Robert Califf said 12/7 during a plenary session at the Milken Institute’s Future of Health Summit in Washington, DC. Improving trial diversity is a top focus of the agency, and earlier
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.” The agency’s pre-submission facility correspondence process was revised as part of the generic drug user fee reauthorization and the guidance is intended to provide the
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Oncologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 9/1/2024. To view the notice, click here.
FDA Policy/General
President Biden 12/2 signed into law HR 8454 “Medical Marijuana and Cannabidiol Research Expansion Act,” which creates a new registration process for conducting research on marijuana and for manufacturing such products for research purposes and drug development. The law directs the Drug Enforcement Administration (DEA) to follow specified procedures
FDA Policy/General
Federal Register notice: HHS has delegated to FDA and NIH authorities under the Accelerating Access to Critical Therapies for ALS [amyotrophic lateral sclerosis; aka Lou Gehrig’s Disease] Act to establish and implement a Public-Private Partnership for rare neurodegenerative diseases. In September, FDA and NIH announced the launch of
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. Nominations are being accepted for current and upcoming vacancies effective 1/1/2023. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available draft guidance #276 entitled “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” The document provides recommendations for the effectiveness evaluation of drugs indicated for preventing heartworm disease caused by Dirofilaria immitis in dogs. To view
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridioides difficile Infection Not Responsive to Standard Therapies.” The document describes the agency’s intended enforcement discretion with respect to IND requirements for
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of Mylan’s Sulfamylon (mafenide acetate, USP) powder for 5% topical solution after the company requested it be withdrawn. The drug was granted accelerated approval in 1998 for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under
FDA Policy/General
Federal Register notice: FDA has issued an order debarring Jennings Ryan Staley for five years from importing or offering for import any drug into the U.S. The debarment is based on Staley’s conviction of one felony count of importing hydroxychloroquine that was then sold as “treatment packs” for
FDA Policy/General
Federal Register notice: FDA has announced a 1/24 Antimicrobial Drugs Advisory Committee meeting. Panel members are scheduled to a discuss a Cidara Therapeutics NDA for rezafungin lyophilized powder for injection, indicated for treating candidemia and invasive candidiasis in adults. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking nominations for voting members to serve on the Medical Devices Advisory Committee device panels. Electronic nominations received on or before 1/27/2023 will be given first consideration for membership on the panels. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 1/9 Dermatologic and Ophthalmic Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Regeneron Pharmaceuticals supplemental BLA for aflibercept solution for intravitreal injection, which was submitted in response to an agency written request for pediatric studies evaluating the therapy’s
FDA Policy/General
Federal Register notice: CDER is proposing to withdraw the approval of an NDA 006499 for Bufferin (aspirin) tablets because it has not received required annual reports. The NDA was approved in 1948 and currently the agency says it has received conflicting information regarding the identity of the current NDA holder.
FDA Policy/General
Federal Register notice: FDA has announced that a priority review voucher was redeemed 6/16 by AbbVie for its supplemental BLA for Skyrizi (risankizumab-rzaa) to expand its indication for treating moderately to severely active Crohn’s disease in adults. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is identifying two bulk drug substances that it has considered and proposes to include on its list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on
FDA Policy/General
The FDA Modeling and Simulation (M&S) Working Group, created in 2016 by the agency’s Office of the Chief Scientist, has issued a report on how M&S is used across and within FDA Centers and the impact it has had on the agency’s mission to