SBIA | Register for "Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use" Webinar

Registration is now open!

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WEBINARS Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use August 10, 2022 1:00 PM - 2:30 PM ET This webinar is FREE. Registration ABOUT THIS WEBINAR  On April 13, 2022, FDA published a draft guidance for industry titled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use. This draft guidance is intended to assist Abbreviated New Drug Application (ANDA) applicants that reference a reference listed drug (RLD) intended for parenteral, ophthalmic, or otic use but are seeking approval of a drug that is qualitatively different or quantitatively different from the RLD with respect to a pH adjuster(s). This webinar will take a deeper look at the draft guidance, expound on the Agency's recommendations to ANDA applicants regarding the submission and content of a waiver request for a difference in pH adjuster, and answer questions submitted to the Federal Register Notice. The webinar will be pre-recorded with a live question and answer session. LEARNING OBJECTIVES Provide an overview of the draft guidance for industry Provide clarification and rationale for the Agency's recommendations for applicants requesting a 314.99(b) waiver for a difference in pH adjuster in an ANDA as compared to the RLD, and FDA's waiver request evaluation process Address questions submitted to the Federal Register Notice This webinar is part of the SBIA Regulatory Education for Industry (REdI) series. INTENDED AUDIENCE Generic drug industry, including current and potential generic drug applicants CONTINUING EDUCATION Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations.  Certificates are only available during the two weeks post-event. This course is: pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant's RAC recertification upon full completion. pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant's RQAP re-registration. approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material. 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

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