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Sharan Murugan
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...
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Sharan Murugan
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...
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