US-FDA Over-The-Counter Monograph Drug User Fee Program (OMUFA)
On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022
The US-FDA Releases White Paper on Testing Methods for Asbestos in Cosmetic Products Containing Talc
On January 13, 2022 , the U.S Food and Drug Administration (FDA) made available the white paper titled IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc (including Talc Intended for Use in Cosmetics).
The US-FDA Grants Citizen Petition on Acacia (Gum Arabic) as a Dietary Fiber
On December 17, 2021, The U.S. Food and Drug Administration (FDA) recently granted a citizen petition concerning the classification of acacia (Gum Arabic) as a dietary fiber.
THE US-FDA: VQIP Application Portal Now Open for FY 2023
On December 1, 2022, the U.S.FDA will Open the Voluntary Qualified Importer Program (VQIP) application portal for fiscal year (FY) 2023.
US-FDA Announces New Requirements to Facilitate Export of Food Under China New Registration – Decree 248
On December 6, 2021 the FDA announced that establishments currently exporting certain food products to China to voluntarily submit information. The FDA is implementing this request in response to new facility registration requirements from China.
THE US-FDA TO MODERNIZE CDER’S EXPORT CERTIFICATE PROGRAM
On December 3, 2021, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) will begin issuing electronic Certificates of Pharmaceutical Product (eCPPs) and will no longer issue or mail paper CPPs.
FDA Releases 2022 New User Fees
The US Food and Drug Administration (FDA) has published the user fees for 2022 that will be collected from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities.
The US FDA Announces OTC Monograph Drug User Fee Rates for FY2021
On December 28, 2020 , the U.S. Food and Drug Administration ( FDA) announced the rates for over the counter (OTC) monograph drug user fees for fiscal year (FY) 2021.
FDA introduces Medical Device User Fee Amendments for Fiscal year 2021
Food and Drug Administration updates lists of Medical Device User Fees for Fiscal year 2021. and increases cost of certain MD submissions.
US FDA releases draft guidance for Cannabis and Cannabis- derived Compounds used in Clinical Research
The US FDA released a new guidance on July 2020 on the clinical research and development of drugs containing cannabis or cannabis derived compounds.
FDA resumes on-site domestic inspection
The United States Food and Drug Administration lifts halt on domestic routine surveillance facility inspections from week of July 20, 2020.
FDA Updates Medical Device Establishments Inspection Processes and Standards
FDA released a final guidance on inspections of medical device establishments requiring reviewing processes and standards applicable to inspections of domestic and foreign device establishments