2020年5月5日 · This guidance provides recommendations to sponsors of new drug applications (NDA's), abbreviated new drug applications (ANDA's), and abbreviated antibiotic applications …

2020年5月5日 · On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

Approval Change (SUPAC) Expert Working Group of the Chemistry Manufacturing Controls Coordinating Committee (CMC CC) of the Center for Drug Evaluation and Research at the …

2014年12月2日 · The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) guidance for industry entitled "SUPAC: …

FDA的法规（21 CFR 314.70 (a)）规定申请人可以根据发表在联邦登记（Federal Register）上的指导原则、通知或条例的规定，对所批准的申请内容实施变更，如此可以减轻繁重的变更通告 …

This draft guidance combines and supersedes the following scale-up and post-approval changes (SUPAC) guidances for industry: (1) SUPAC-IR/MR: Immediate Release and Modified …

What is SUPAC? SUPAC is scale-up and the post-approval changes (changes that are made after approval) like in the formulation of the drug, batch size, process, equipment, site of …

2022年1月11日 · FDA’s latest guidance, SUPAC: Manufacturing Equipment Addendum, is dedicated to creating a holistic set of recommendations about how to support proposed …

2020年5月5日 · On November 30, 1995, the Scale-up and Post-Approval Changes Guidance for Immediate Release Products (SUPAC-IR) was published. Since then a number of questions …

This FDA Guideline refers to post-approval changes concerning immediate-release solid oral dosage forms