Consultation Deadlines

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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.
16th August 2018
EMA Scientific guideline: ICH guideline Q3D (R1) on elemental impurities – Step 2b, draft: consultation open.
17th August 2018
FDA draft guidance for industry entitled “Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations.”
20th August 2018
FDA draft guidance for industry entitled “Major Depressive Disorder: Developing Drugs for Treatment.”

FDA draft guidance for industry entitled “Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.”

28th August 2018
FDA draft guidance for industry entitled “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.”
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.
31st August 2018
EMA Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consultation open.
4th September 2018
FDA draft guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.”
7th September 2018
FDA draft guidance for industry entitled “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.”
10th September 2018
European Commission targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products.

FDA draft guidance for industry entitled “Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.”

11th September 2018
FDA draft guidance for industry, FDA staff, and other stakeholders entitled “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.”
13th September 2018
EMA Scientific guideline: Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, draft: consultation open.
14th September 2018
FDA draft guidance for industry entitled “Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs.”
17th September 2018
FDA draft guidance for industry entitled “Field Alert Report Submission: Questions and Answers.”

FDA draft guidance for industry entitled “Innovative Approaches for Nonprescription Drug Products.”

23rd September 2018
MHRA Open consultation: Implementing ‘safety features’ under the Falsified Medicines Directive.
24th September 2018
FDA draft guidance for industry entitled “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.”

FDA draft guidance for industry entitled “Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments.”

25th September 2018
FDA draft guidance for industry entitled “Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.”
30th September 2018
EMA Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances, draft: consultation open.
5th October 2018
FDA draft guidance for industry entitled “Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.”
9th October 2018
FDA draft guidance for industry entitled “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.”
10th October 2018
FDA draft guidance for industry entitled “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry.”

FDA draft document entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry.”

FDA draft document entitled “Human Gene Therapy for Rare Diseases; Draft Guidance for Industry.”

FDA draft document entitled “Human Gene Therapy for Hemophilia; Draft Guidance for Industry.”

FDA draft document entitled “Long Term Follow-Up After Administration of Human Gene Therapy Products; Draft Guidance for Industry.”

FDA draft document entitled “Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry.”

12th October 2018
FDA draft guidance for industry entitled “Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.”
22nd October 2018
EMA Scientific guideline: Draft guideline on manufacture of the veterinary finished dosage form – Revision 1, draft: consultation open.
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.

15th December 2018
FDA guidance entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation.”
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.
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.
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.