Quantcast
Channel: ANDA
Browsing index pages (5 articles)

ANDA Submissions-Content and Format

Guidance for Industry By Global Compliance Seminar (LinkedIn; Twitter) ANDA Submissions-Content and Format of Abbreviated New Drug Applications June 2014 Generics This guidance is intended to assist...

View Article


Questions and Answers for ANDAs Stability Testing

FDA Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers May 2014 This guidance provides answers to questions from the public (more…)

View Article


ANDA Submissions – Refuse-to-Receive Standards

Guidance for Industry By Global Compliance Seminar (LinkedIn; Twitter) ANDA Submissions – Refuse-to-Receive Standards May 2015 Generic Drugs Revision 1 This guidance is intended to assist applicants...

View Article

FDA ANDA Submissions-Content and Format

Guidance for Industry ANDA Submissions-Content and Format of Abbreviated New Drug Applications This guidance is intended to assist applicants in preparing abbreviated new drug applications (more…)

View Article

FDA Guidance for Generic Asthma Drugs

FDA Guidance for Industry Draft Guidance on Fluticasone Propionate; Salmeterol Xinafoate Active ingredient: Fluticasone Propionate; Salmeterol Xinafoate Form/Route: Powder/Inhalation Recommended...

View Article

Browsing index pages (5 articles)


Latest Images