Unggahan by Markbot1999

Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants November 2015 Procedural 15085fnl

Bioeqivalence Recommendations for Specific Products 8857fnl.pdf

Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System DRAFT May 2015 Rev 1 ucm070246.pdf

Bioeqivalence Recommendations for Specific Products 8857fnl

Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System DRAFT May 2015 Rev 1 ucm070246.pdf

Designation of Official Names and Proper Names for Certain Biological Products Propose Rule 2015-21382

Referencing Approved Drug Products in ANDA Submissions DRAFT 01-2017 Generics.pdf

MAPP 5240.3 Rev.2 Prioritization of the Review of Original ANDAs, Amendments, and Supplements.pdf

Off-Patent Off-Exclusivity Drug List with no Generic 2017-10-30.pdf

Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn July 2016 Generics 3048879dft.pdf

Stability Guidance & Draft Q&A Guidance considerations FDA Small Business WEBINAR 2013-11-04 UCM373234.pdf

Inspections and ANDA Review CDER OC OMQ’s Role Francis Godwin OMQ CDER GPhA Fall 2016

Good ANDA Submission Practices DRAFT January 2018 Generics.pdf

RLD - reference standard - BOS draft guidance webinar 1-18-17.pdf

Good Abbreviated New Drug Application Assessment Practices MAPP 5241.3 2018-01-03

Good ANDA Submission Practices DRAFT January 2018 Generics.pdf

Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft June 2016 Generic Drugs.pdf

Controlled Correspondence Related to Generic Drug Development September 2015 Generics.pdf

ANDA Submissions Amendments and Easily Correctable Deficiencies Under GDUFA July 2014 Generic Drugs DRAFT.pdf

ANDA Submissions Refuse-to-Receive Standards Guidance for Industry May 2015 Generic Drugs Revision 1.pdf

ANDAs Stability Testing of Drug Substances and Products Questions and Answers May 2014 Generics CDER2013213 guidance May2.pdf

ANDA Submissions Refuse to Receive for Lack of Justification of Impurity Limits 20160810.pdf

ANDA Submissions Refuse-to-Receive Standards December 2016 Generics Revision 2.pdf

ANDAs Stability Testing of Drug Substances and Products June 2013 Generics 10956fnl ANDAs_ 5-6-2013 CLEAN.pdf

ANDA Submissions Prior Approval Supplements Under GDUFA October 2016 Generics

Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs DRAFT April 2015

Communications With Industry With Respect to Pre-GDUFA Year Three ANDAs MAPP 5200.3 Rev. 1

Webinar - Amendments and Easily Correctable Deficiencies Under GDUFA 063014

ANDA Submissions Amendments and Easily Correctable Deficiencies Under GDUFA July 2014 16478dft_07-09-14.pdf

ANDA Submissions Prior Approval Supplements Under GDUFA DRAFT July 2014 16479dft_07-09-14.pdf

Self-Identification of Generic Drug Facilities Sites and Organizations September 2016 Generics GDUFA Self ID Final Guidance2

Day2.4 - Mozzachio - Post-Approval and Surveillance Inspection

Day2.2 - Lionberger - GDUFA Regulatory Science

Day1.6 - Zhang - DMFs With a GDUFA Perspective

Day1.7 - Song - Completeness Assessment for TYpe II API DMF Under GDUFA

Day1.5 - Shaw - Drug Master File (DMF) Basics

Day1.4 - Lantzy - Optimizing Your eCTD ANDA

Day1.3 - Lee - A Filing Reviewer's Perspective

Day2.6 - Park - GDUFA Review Efficiency Enhancements

Day1.2 - Young - An Overview of the Draft Guidance for Industry - ANDA Submissions RTR

FDA Perspectives - Scientific Considerations of Forced Degradation Studies in ANDA Submissions Ragine Maheswaran MAY 2012

Process Validation General Principles and Practices January 2011 Revision 1 9365fnl

- 879 CHAPTER 64E-16 BIOMEDICAL WASTE

Vitamin B New Research