SBIA: Recordings Available for Generic Drugs Forum 2021: Lifecycle of a Generic Drug

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance CONFERENCES Generic Drugs Forum 2021: Lifecycle of a Generic Drug Selected recordings are available below for your reference. Feel free to forward this email to colleagues and share recordings via social media.  View All Conference Recordings Bioavailability/Bioequivalence (BA/BE) Studies Premarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms Data Integrity Issues in Bioequivalence Studies Addressing Common Challenges in BE Studies  Bioavailability/Bioequivalence Site Evaluation  Pre-ANDA Program and FDA Consultation Pre-ANDA Program Pre-ANDA Program Update and Tips for Success – Office of Pharmaceutical Quality Perspective Controlled Correspondence Related to Pharmaceutical Quality  Mid-Review Cycle Meeting Overview ANDA Application Information to Include with Cover Letters Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence Application Communications – Quality Assessment Perspective Building a Better Sterility Assurance Application Impact of Data Integrity Issues on Pharmacology/Toxicology Studies in ANDAs Assessment of Extractables/Leachables Data in ANDA Submissions Integrated Manufacturing Assessment: Expectations Insights from Records Requests under §704(a)(4) of the FD&C Act in lieu of Pre-Approval Inspections Lab Science to Support Generic Complex Drug Product Assessment ANDA Labeling: Recommendations and Helpful Resources  Postmarket ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues Postmarketing Safety and Surveillance of Generic Drugs Update Update on Shared System REMS for Generic Drugs The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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