Consultation Deadlines

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22nd October 2018
EMA Scientific guideline: Draft guideline on manufacture of the veterinary finished dosage form – Revision 1, draft: consultation open.

FDA draft guidance for industry entitled “Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment.”

23rd October 2018
FDA draft guidance for industry entitled “Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development.”
30th October 2018
EMA Scientific guideline: Draft guideline on clinical evaluation of vaccines – Revision 1, draft: consultation open.
31st October 2018
EMA Scientific guideline: Second draft guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals, draft: consultation open.

European Commission Targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products.

EMA Scientific guideline: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open.

1st November 2018
MHRA consultation on how its legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period.
13th November 2018
FDA draft guidance for industry entitled “Postapproval Changes to Drug Substances.”
19th November 2018
FDA draft guidance for industry entitled “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.”
26th November 2018
FDA draft guidance for industry entitled, “Insanitary Conditions at Compounding Facilities.”
30th November 2018
EMA Scientific guideline: Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products – Revision 3 , draft: consultation open.

EMA Scientific guideline: Draft guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products – Revision 3 , draft: consultation open.

EMA Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open.

FDA draft guidance for industry entitled “Adaptive Designs for Clinical Trials of Drugs and Biologics.”

FDA draft guidance for industry entitled “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.”

FDA draft guidance for industry entitled “Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to an IND, NDA, BLA, or ANDA.”

3rd December 2018
FDA draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.”
10th December 2018
FDA draft guidance for industry entitled “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.”

FDA revised draft guidance for industry entitled “Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.”

15th December 2018
FDA guidance entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation.”
16th December 2018
EMA Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate – Revision 1: 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.
21st December 2018
EMA Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open.
24th December 2018
FDA draft guidance for industry and review staff entitled “Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.”
31st December 2018
EMA Scientific guideline: Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV – First version, draft: consultation open.
15th January 2019
EMA Scientific guideline: Draft guideline on the use of adjuvanted veterinary vaccines, draft: consultation open.
31st January 2019
EMA Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation, draft: consultation open.
6th February 2019
EMA Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers – Step 2b – First version, draft: consultation open.
15th February 2019
EMA Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) – Revision 1, draft: consultation open.
17th February 2019
EMA Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders – Revision 3, draft: consultation open.
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.

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.