Consultation Deadlines

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24th June 2019
FDA draft guidance for industry and FDA staff entitled “Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.”

FDA draft guidance for industry entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes.”

30th June 2019
EMA Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations, draft: consultation open.

EMA Scientific guideline: Concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease (CHMP/EWP/714/98 rev 1), draft: consultation open.

EMA Scientific guideline: Guideline on the non-clinical requirements for radiopharmaceuticals, draft: consultation open.

EMA Scientific guideline: Paediatric addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease, draft: consultation open.

EMA Scientific guideline: Guideline on clinical investigation of recombinant and human plasma-derived factor IX products – Revision 2, draft: consultation open.

EMA Scientific guideline: Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products – Revision 3, draft: consultation open.

EMA Scientific guideline: Guideline on the environmental risk assessment of medicinal products for human use – Revision 1, draft: consultation open.

EMA Scientific guideline: Guideline on quality and equivalence of topical products, draft: consultation open.

EMA Scientific guideline: Concept paper on a guideline for allergen products development in moderate to low-sized study populations, draft: consultation open.

EMA Regulatory Science to 2025 – Strategic Reflection, draft: consultation open.

EMA Scientific guideline: Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections – Revision 3, draft: consultation open.

5th July 2019
FDA draft guidance for industry entitled “Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment.”
8th July 2019
FDA draft guidance for industry entitled “Postapproval Pregnancy Safety Studies.”

FDA draft guidance for industry entitled “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.”

FDA draft guidance for industry entitled “Clinical Lactation Studies: Considerations for Study Design.”

22nd July 2019
FDA draft guidance for industry entitled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.”
31st July 2019
EMA Scientific guideline: Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury, draft: consultation open.

EMA Scientific guideline: Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open.

EMA Scientific guideline: Draft questions and answers on Data Monitoring Committees issues, draft: consultation open.

EMA, HMA and European Commission (EC) public consultation on draft key principles which will form the basis on which the electronic product information (ePI) for human medicines will be developed and used in the European Union.

1st August 2019
EMA Scientific guideline: Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials, draft: consultation open.
6th August 2019
FDA draft guidance for industry entitled “Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment.”

FDA draft guidance for industry entitled “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs.”

8th August 2019
EMA Scientific guideline: Guideline on clinical investigation of medicinal products for the treatment of gout, draft: consultation open.
20th August 2019
FDA draft guidance for industry entitled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.”
31st August 2019
EMA Scientific guideline: Draft guideline on data requirements for veterinary medicinal products for the prevention of transmission of vector-borne diseases in dogs and cats, draft: consultation open.

EMA Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances – Revision 1, draft: consultation open.

EMA Scientific guideline: Reflection paper on resistance in ectoparasites, draft: consultation open.

EMA Scientific guideline: Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), draft: consultation open.

EMA Scientific guideline: Reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products, draft: consultation open.

EMA Scientific guideline: Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products, draft: consultation open.

EMA Scientific guideline: Revised guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, draft: consultation open.

EMA Scientific guideline: Guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats, draft: consultation open.

EMA Scientific guideline: Guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances, draft: consultation open.

EMA Scientific guideline: Draft guideline on the quality requirements for drug-device combinations.

1st September 2019
EMA Scientific guideline: Draft ICH guideline M10 on bioanalytical method validation – Step 2b, draft: consultation open.
29th September 2019
EMA Scientific guideline: Draft ICH guideline E19 on optimisation of safety data collection – Step 2b, draft: consultation open.
30th September 2019
EMA Scientific guideline: Reflection paper on the qualification of non-genotoxic impurities, draft: consultation open.

EMA Scientific guideline: ICH guideline E8 (R1) on general considerations for clinical studies – Step 2b, draft: consultation open.

31st October 2019
EMA Scientific guideline: CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products – Revision 3, draft: consultation open.