Upcoming CDER Meetings and Conferences - July through September

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . Upcoming CDER Meetings and Conferences   Visit CDER's Meetings, Conferences, & Workshops (Drugs) webpage for more information. July July 12-13: Safe Use of Benzodiazepines: Clinical, Regulatory, and Public Health Perspectives July 15: Cardiovascular and Renal Drugs Advisory Committee Meeting July 19-23: SBIA Regulatory Education for Industry (REdI) Annual Conference (Featuring CDER, CDRH & CBER) July 21: Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) Workshop on Eosinophilic Gastrointestinal Disorders Beyond EoE July 22: Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) Workshop on Celiac Disease August Aug. 18-20: FDA and Center for Research on Complex Generics Co-Hosted Workshop: In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions September Sep. 21: Considerations for Progressive Multifocal Leukoencephalopathy Clinical Trial Designs Sep. 21-22: SBIA Advancing Generic Drug Development: Translating Science to Approval Sep. 22: FDA-NRC Workshop: Targeted Alpha Emitting Radiopharmaceuticals, with Focus on Ac-225 Recent SBIA Recordings Posted Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Identification of Medicinal Products: Path to Global Implementation FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond: CDERLearn Course OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar Generic Dugs Forum 2021: Lifecycle of a Generic Drug 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. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA