FDA
Clinical, General, Procedural
19/04/18
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations
Post-approval
26/02/18
Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)—Questions and Answers
Clinical, Procedural
21/11/17
General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products
EMA
01/10/17
Guideline on clinical development of fixed combination medicinal products
ICH
General, Clinical, Post-approval
18/09/17
Q4B Annex 2(R1): Test for Extractable Volume of Parenteral Preparations General Chapter
Clinical, Procedural, Post-approval
30/06/17
Concept paper on revision of the guideline on the pharmaceutical quality of inhalation and nasal products
Procedural
21/01/17
Guideline on the chemistry of active substances
Procedural, General
17/01/17
2016 Medical Gas Container-Closure Rule Questions and Answers
Clinical, Post-approval
05/04/18
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation
Clinical, General
15/02/18
Regulatory Classification of Pharmaceutical Co-Crystals
03/11/17
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry
30/09/17
Concept paper on revision of the Guideline on clinical development of vaccines
20/07/17
Guideline on manufacture of the finished dosage form
Procedural, Post-approval
29/06/17
Current Good Manufacturing Practice for Medical Gases
18/01/17
Assessment of Abuse Potential of Drugs
13/01/17
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
General, Post-approval
18/01/18
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
11/10/17
Completeness Assessments for Type II API DMFs Under GDUFA
Clinical, General, Post-approval
29/09/17
Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization
Clinical
Concept paper on a revision of the Guideline on the investigation of drug interactions
14/06/17
ICH guideline Q3C (R6) on impurities: guideline for residual solvents
Post-approval, Clinical
Nonproprietary Naming of Biological Products
General
11/01/17
Current Good Manufacturing Practice Requirements for Combination Products
