2013 PDA Regulatory Comments

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Parenteral Drug Association Connecting People, Science and Regulation ^®

EU Commission Draft Guidance on Similar Biological Medicinal Products 30 Oct 2013

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EU Commission Draft Guidance on Use of Porcine Trypsin Used in Manufacture of Human Biological Medicinal Products 8 Oct 2013

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FDA Draft Guidance on Delaying Denying Limiting or Refusing a Drug Inspection 13 Sep 2013

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FDA Proposed Rule on Administrative Detention of Drugs 13 Sep 2013

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FDA Draft Guidance on Contract Manufacturing Arrangements for Drugs 29 Jul 2013

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EU Commission Draft of GMP Chapter <5> Production 25 Jul 2013

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EU Commission Draft of GMP Chapter <3> Premises and Equipment 24 Jul 2013

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EU Commission Draft of GMP Chapter <6> Quality Control 18 Jul 2013

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EU Commission Draft of GMP Chapter <8> Complaints Quality Defects and Product Recalls 18 Jul 2013

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FDA Draft Guidance on Glass Syringes for Delivering Drug and Biological Products 2 Jul 2013

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EU Commission Draft Guidance on Setting Health Based Exposure Limits for Use 26 Jun 2013

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EU Commission Draft Guidance on GMP for Excipients of Medicinal Products for Human Use 30 Apr 2013

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EU Commission Draft Guidance on Principles of Good Distribution Practices for Active Substances for Medicinal Products for Human Use 30 Apr 2013

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EU Commission Draft Template on GMPCompliance of Investigational Medicinal Products Manufactured in Non-EU Countries 2 Apr 2013

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WHO Draft Guidance on GMP for Pharmaceutical Products 28 Mar 2013

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USP Proposed In-Process Revision to General Notice Section 5 Monograph Components 26 Mar 2013

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FDA Draft Guidance on Drug Shortages Strategic Plan 13 Mar 2013

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