Consultation Deadlines

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17th April 2018
FDA draft guidance for industry entitled “Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older.”

FDA draft guidance for industry entitled “Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment.”

23rd April 2018
European Commission roadmap entitled “Communication from the Commission on Improving Health Security in the EU – a one health approach to counteracting the threat from infectious diseases.”
30th April 2018
EMA Scientific guideline: Draft guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease, draft: consultation open.

EMA Scientific guideline: Concept paper on the development of a reflection paper on new analytical methods/technologies in the quality control of herbal medicinal products, draft: consultation open.

FDA draft guidance entitled “E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.”

EMA Scientific guideline: Draft guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products – Rev. 1, draft: consultation open.

1st May 2018
FDA draft guidance for industry entitled “Standardization of Data and Documentation Practices for Product Tracing.”
11th May 2018
FDA draft guidance for industry #240 entitled “Proprietary Names for New Animal Drugs.”
14th May 2018
EMA Scientific guideline: Public consultation concerning a request for CVMP opinion under Article 30(3) of Regulation (EC) No 726/2004 on the risk for the consumer resulting from the use of diethanolamine as an excipient in veterinary medicinal products for food-producing species (EMEA/V/A/127), draft: consultation open.
15th May 2018
EMA Scientific guideline: Public consultation concerning the European Union template for good manufacturing practice (GMP) non-compliance statement, draft: consultation open.
17th May 2018
FDA draft guidance for industry entitled “Early Alzheimer’s Disease: Developing Drugs for Treatment.”
21st May 2018
FDA draft guidance for FDA staff and industry entitled “Drug Products Labeled as Homeopathic.”
25th May 2018
FDA draft guidance for industry entitled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.”
29th May 2018
FDA draft guidance for industry (GFI) #255 entitled “Elemental Impurities in Animal Drug Products—Questions and Answers.”
31st May 2018
EMA Scientific guideline: Draft guideline on conduct of pharmacokinetic studies in target animal species – Revision 1, draft: consultation open.
8th June 2018
FDA draft guidance for industry entitled “Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.”

FDA draft guidance for industry entitled “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.”

15th June 2018
EMA Scientific guideline: Draft VICH GL57 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species, draft: consultation open.
19th June 2018
FDA draft guidance for industry and FDA staff entitled “Postmarketing Safety Reporting for Combination Products.”
15th August 2018
EMA Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus – Revision 2, draft: consultation open.
30th August 2018
EMA Scientific guideline: Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements – First version, draft: consultation open.
18th December 2018
EMA Scientific guideline: Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management – Step 2b – First version, draft: consultation open.