Consultation Deadlines

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22nd June 2018
FDA draft guidance for industry entitled “Opioid Dependence: Developing Depot Buprenorphine Products for Treatment.”
25th June 2018
FDA draft guidance for industry entitled “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.”
9th July 2018
FDA draft guidance for industry entitled “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.”
13th July 2018
FDA draft guidance for industry entitled “Pediatric HIV Infection: Drug Development for Treatment.”
23rd July 2018
FDA draft guidance for industry entitled “Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.”
30th July 2018
FDA draft guidance entitled “Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.”

FDA draft guidance for industry entitled “Assessment of Pressor Effects of Drugs.”

31st July 2018
FDA draft guidance for industry entitled “Development of a Shared System REMS.”

FDA draft guidance for industry entitled “Waivers of the Single, Shared System REMS Requirement.”

2nd August 2018
European Commission Public Consultation: Study supporting the Evaluation of the European Medicines Agency Fee System.
3rd August 2018
FDA draft guidance for industry entitled “Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.”
6th August 2018
FDA draft guidance for industry entitled “Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief.”
8th August 2018
FDA draft guidance for industry entitled “Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment.”
13th August 2018
FDA draft guidance for industry entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.”

FDA draft guidance for industry entitled “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.”

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.”

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.”
10th September 2018
European Commission targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products.
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.
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.
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.
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.