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Jun 5, 20231 min read

USFDA Guidance: Cover Letter Attachments for Controlled Correspondences & ANDA Submissions

The United States Food & Drug Administration published the final guidance "Cover Letter Attachments for Controlled Correspondences and...

Apr 17, 20221 min read

FDA's MAPP on Complex Product Classification for Generic Development

On 13 April 2022, the FDA's Office of Generic Drugs (OGD) published a draft manual of policies and procedures, (MAPP 5240.10) outlining...