Brazil’s Anvisa and FDA Renew Declaration of Technical Cooperation
On March 8, 2022 Brazil’s Anvisa and the U.S. Food and Drug Administration (FDA) have signed a Cooperation Statement aimed at maintaining and strengthening their collaboration mechanisms.
REGISTRATION OF DRUG MASTER FILE (DMF) IN JAPAN
In Japan, the Drug Master File (DMF) is called “Master File” or “MF”. The Purpose of DMF is to protect the “know-how” of API manufacturing methods against the marketing authorization applicant (MAA) / holder (MAH) of pharmaceutical products. The foreign manufacturers of APIs can apply for DMF registration.
US-FDA Formal Meetings with OTC Sponsors
Overview: On February 1st, 2022, the US Food and Drug Administration (FDA) issued a draft of guidance on formal meetings between sponsors of over-the counter (OTC) monograph drugs and the agency.The guidance clarifies how sponsors can obtain advice on studies to support their submissions. It also addresses meeting types, meeting formats, content of meeting requests […]
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 deems final Order for Sunscreens
On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.
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.
FDA publishes ICH Q12 guideline for Post Approval CMC changes
Overview FDA facilitates the management of post approval CMC to harmonize regulatory approval of drugs with ICH Q12 guideline. This guidance applies to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization and to drug-device combination products that meet the definition of a pharmaceutical or biological product. Regulatory tools and […]
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.