2015 PDA Regulatory Comments

Join/Renew |
Login

Login to Your PDA Account

Don't have an account yet? Create an Account Forgot your username or password? Recover account

Parenteral Drug Association Connecting People, Science and Regulation ^®

GMP for Advanced Therapy Medicinal Products 12 Nov 2015

(?)
FDA Guidance for Industry Request for Quality Metrics 12 Nov 2015

(?)
EDQM Biological Indicators and Related Microbial Preparations 25 Sep 2015

(?)
FDA Draft Guidance for Industry Established Conditions 20 Aug 2015

(?)
FDA Guidance for Industry Mixing Diluting or Repackaging Biological Products 20 May 2015

(?)
WHO Proposal for Revision of Good Trade and Distribution Practices for Pharmaceutical Starting Materials 12 May 2015

(?)
FDA Guidance for Industry Good Manufacturing Practices for Combination Products 27 Apr 2015

(?)
FDA Draft Guidance for Industry Investigating and Reporting Adverse Reactions 21 April 2015

(?)
WHO Good Pharmacopoeial Practices QAS13.526 30 Mar 2015

(?)
FDA Draft Guidance for Human Cells Tissues and Cellular and Tissue-Based Products from Adipose Tissue 23 Feb 2015

(?)
FDA Draft Guidance for Minimal Manipulation of Human Cells Tissues and Cellular and Tissue-Based Products 23 Feb 2015

(?)
EC Annex 17 Real Time Release 17 Dec 2015

(?)