FDA Policy/General
Former FDA associate commissioner for women’s health Susan Wood has died at her home in London at the age of 66 after battling glioblastoma (brain cancer). In 2005, Wood resigned from the agency in protest over the agency’s decision to delay over-the counter approval of the morning-
FDA Policy/General
Three Ropes & Gray attorneys write in their 2024 FDA Enforcement Review that while the agency’s focus may shift with the new administration, “industry should continue to invest in strong regulatory compliance and quality programs that encourage the reporting and thorough investigation of potential problems and facilitate prompt corrective
FDA Policy/General
Sens. Dick Durbin (D-IL) and Charles Grassley (R-IA) have reintroduced their Drug-price Transparency for Consumers (DTC) Act that would require price disclosures in prescription drug ads. The senators say their bill would empower patients and reduce spending on medications. There are six bipartisan co-sponsors of the
FDA Policy/General
The National Treasury Employees Union (NTEU), which represents some 150,000 employees in 37 federal agencies and departments, including FDA, has filed suit in the DC federal court opposing President Donald Trump’s executive order to use Schedule F to convert federal nonpartisan career positions into “political favors for loyalists.
FDA Policy/General
The Trump Administration has placed FDA and other government health agencies under an external communications embargo until 2/1. The move, which previous administrations have also ordered in their early transition days, reportedly gives the agencies time for the new political appointees to set up their review and approval of
FDA Policy/General
Federal Register notice: FDA is amending its regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during 10/2024, 11/2024, and 12/2024. The regulations are also being amended to improve accuracy and readability. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking public comments on the use of cannabis-derived products (CDPs) in animals. The agency says it wants to learn more about general trends associated with CDPs, including information about: usage trends (e.g., product selection, indications, etc.), quality standards, benefits of use, potential drug
FDA Policy/General
Voicing the belief that FDA commissioner-nominee Martin Makary can have a successful tenure at the agency, commissioner Robert Califf, former commissioners Scott Gottlieb and Mark McClellan, and former acting commissioner Janet Woodcock used their time on a panel at the 2025 Summit sponsored by the University of California San
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Recommendations To Reduce the Risk of Transfusion — Transmitted Malaria.” The document recommends selectively testing blood donations from donors at risk for malaria using an FDA-licensed donor screening nucleic acid test (NAT) for Plasmodium species, which cause malaria. To
FDA Policy/General
King & Spalding has added former FDA associate commissioner for policy Lauren Roth as a partner on the FDA and Life Sciences team in the firm’s Washington, D.C. office. Roth left FDA 9/2024 after serving eight years in senior leadership roles, such as senior advisor to FDA’
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 23 ANDAs from multiple applicants after they told the agency that the drug products were no longer marketed and requested such action. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing that it has issued Novo Nordisk a priority review voucher because its rare pediatric disease product, Alhemo (concizumab-mtci), met the agency’s issuance criteria. The product was approved 12/20/2024 as a once-a-day treatment to prevent or curb the frequency
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of 12 NDAs from multiple applicants after they requested their withdrawal because the affected products are no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Generic Drug User Fee Program.” The revision is related to the agency’s communication program that encourages the submission of sponsor questions at any point in their development and application preparation processes. The collection is being revised
FDA Policy/General
Over 18,000 physicians have recently signed an open letter urging the U.S. Senate to reject incoming president Donald Trump’s nomination of Robert F. Kennedy Jr. to serve as HHS secretary. “As physicians who care deeply about the health and safety of our patients and communities, we are
FDA Policy/General
Federal Register notice: FDA announces that a priority review voucher was used with the agency’s 12/20/2024 approval of Vertex Pharmaceuticals’ Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator modulator for treating cystic fibrosis in people six years and
FDA Policy/General
Federal Register notice: The FDA is announcing it has issued a priority review voucher to Neurocrine Biosciences because its 12/13 NDA approval for Crenessity (crinecerfont) was a qualifying action. The drug was approved to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Developing Drugs for Optical Imaging.” The document provides recommendations on clinical trial design features that support development and approval of optical imaging drugs that are used in conjunction with imaging devices and intended as intraoperative aids for detecting tumors
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction.” The document provides recommendations on developing drugs/biological products intended for reduction and long-term maintenance of body weight in obese/overweight patients. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is correcting a 12/5/2024 debarment notice against Yong Sheng Jiao (also known as Yongsheng Jiao and Wilson Jiao). The new notice indicates that Jiao is debarred for five years from importing or offering for import any drug into the U.S. FDA bases the
FDA Policy/General
The FDA Center for Veterinary Medicine (CVM) says its evaluation of adverse events reported in dogs of various ages treated with Zoetis’ Librela (bedinvetmab injection) found ataxia; seizures; other neurologic signs including paresis, recumbency, urinary incontinence, polyuria, and polydipsia. A CVM statement says Librela, a monoclonal antibody drug used to
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Advanced Manufacturing Technologies (AMT) Designation Program.” The document provides recommendations on participating in the program, which facilitates the development of drugs manufactured using a designated AMT. To view the notice, click here.