💊Mylan Inc. Seeks Registration for Controlled Substance Importing
Mylan Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More⚖️DOJ Notice on Organic Consultants LLC Controlled Substances Application
Organic Consultants LLC DBA Cascade Chemistry has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊FDA Notice on Type V Drug Master Files for ANDA Support
The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs is establishing a public docket entitled "Use of a Type V Drug Master File (DMF) for Model Master File (MMF) Submissions to Support Abbreviated New Drug Applications (ANDAs)." The purpose of this docket to solicit input from interested parties on this topic.
Learn More⚙️FDA Guidance on Advanced Manufacturing Technologies for Pharmaceuticals
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Advanced Manufacturing Technologies Designation Program." FDA encourages the early adoption of advanced manufacturing technologies (AMTs) by the pharmaceutical industry, which can improve the reliability and robustness of the manufacturing process and can benefit patients by enhancing product quality and reducing drug development time or increasing or maintaining the supply of drugs that are life-supporting, life-sustaining, of critical importance to providing health care, or in shortage. This guidance provides recommendations to persons and organizations interested in participating in FDA's Advanced Manufacturing Technologies Designation Program, which facilitates the development of drugs manufactured using an AMT that has been designated as such under the program. The guidance finalizes the draft guidance of the same title issued on December 13, 2023.
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