Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against ...
The regulations for food and drugs in the United States, described in Title 21 of the Code of Federal Regulations (CFR), are critical in ensuring safe and ethical drug administration. Whether you are ...
Dublin, Jan. 16, 2026 (GLOBE NEWSWIRE) -- The "GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries (Jan 28th - Jan 29th, 2026)" training has been added to ...
Akadeum has been successfully customer-audited per US and EU GMP standards, and the products meet endotoxin, sterility, and viral requirements per USP and ICH standards. As expected for raw materials ...
The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA): Standardized ...
FREMONT, Calif.--(BUSINESS WIRE)-- Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing ...
(RTTNews) - Bio-Techne Corp. (TECH) announced Wednesday that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ExCellerate GMP iPSC Expansion Medium, ...
SHANGHAI, Jan. 16, 2023 /PRNewswire/ -- OBiO Technology (Shanghai) Corp., Ltd. ('OBiO', 688238.SH), a gene and cell therapy-focused contract research organization (CRO) and contract development and ...
ANN ARBOR, Mich., Nov. 18, 2025 /PRNewswire/ -- Akadeum Life Sciences, the leader in buoyant cell separation, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S. Food ...
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