Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs
Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs
FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in Oncology
The FDA issued a draft guidance that, when finalized, will provide sponsors with recommendations on multiregional clinical trials (MRCT) conducted to support applications for drugs intended to treat cancer.
FDA Roundup: September 13, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Types of FDA Inspections
The FDA conducts several types of inspections to help provide access to needed medical products and to protect consumers and patients from unsafe products:
UPDATED AGENDA INFORMATION: September 13, 2024: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement - 09/13/2024
September 13, 2024: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement
FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection
On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as th
UPDATED PUBLIC PARTICIPATION INFORMATION: August 2, 2024: Meeting of the Genetic Metabolic Diseases Advisory Committee Meeting Announcement - 08/02/2024
August 2, 2024: Meeting of the Genetic Metabolic Diseases Advisory Committee Meeting Announcement
Drug Trials Snapshots: LAMZEDE
LAMZEDE is an enzyme replacement therapy that is used for the treatment of adult and pediatric patients with alpha-mannosidosis.
FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause. Stop Medicine if Signs and Symptoms of Liver Injury Occur - Drug Safety Communication
The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury,
FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause
FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause. Stop medicine if signs and symptoms of liver injury occur.
Join FDA for the First National Hispanic/Latino Family Cancer Awareness Week, Sept. 20-26
Project Community within the U.S. Food and Drug Administration’s Oncology Center of Excellence (OCE) will hold the first National Hispanic/Latino Family Cancer Awareness Week Sept. 20-26, 2024, to inc
FDA-CDER and HESI | Nitrosamine Ames Data Review and Method Development Workshop - 10/15/2024
The Food and Drug Administration Center for Drug Evaluation and Research and Health & Environmental Sciences Institute Global agree to co-sponsor the Nitrosamine Ames Data Review and Method Develo
Innovation Bakers, LLC Issues Allergy Alert on Undeclared Walnut in 7-Eleven Fudge Brownie Distributed in Southern California
Innovation Bakers, LLC of Fullerton, CA, is issuing a voluntary limited recall of one day’s production of its 3.5 oz packs of 7-Eleven Fudge Brownie (05254856392) because they may contain undeclared w
Drug Trials Snapshots: IMDELLTRA
IMDELLTRA is a drug approved for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC), whose cancer has progressed after prior treatment with chemotherapy that contains platinum.
FDA Rare Disease Innovation Hub
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.
FDA Roundup: September 10, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Drug Trials Snapshots: ELFABRIO
ELFABRIO is an enzyme replacement therapy that is used for the treatment of Fabry disease in adult patients.
Streamlining Drug Development and Improving Patient Care: CDER Quantitative Medicine Center of Excellence
Streamlining Drug Development and Improving Patient Care: CDER Quantitative Medicine Center of Excellence
BsUFA III: Fiscal Years 2023-2027
New legislation will be required for FDA to continue collecting biosimilar user fees in future fiscal years. Information related to FDA’s preparation for the third reauthorization of BsUFA will be hosted here on this page as it becomes available.