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USFDA GUIDElINES (Generic Drug )

180-Day Exclusivity When Multiple Abbreviated New Drug Applications Are Submitted on the Same Day (I)


Abbreviated New Drug Applications: Impurities in Drug Products


ANDAs: Impurities in Drug Substances; Chemistry, Manufacturing and Controls Information (I)


ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing and Controls Information (I)


ANDA Submissions – Prior Approval Supplements Under GDUFA (DRAFT)


ANDA Submissions – Amendments and Easily (DRAFT)


ANDA Submissions — Refuse-to-Receive Standards


Handling and Retention of Bioavailability and Bioequivalence Testing Samples (I)


Revising ANDA Labeling Following Revision of the RLD Labeling (I)


Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules


Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (I)


Variations in Drug Products that May Be Included in a Single ANDA (I)



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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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