Consultation Deadlines

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27th August 2019
FDA draft guidance for industry entitled “Treatment for Heart Failure: Endpoints for Drug Development.”
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.
3rd September 2019
FDA draft guidance for industry entitled “Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.”

FDA draft guidance for industry entitled “Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format.”

9th September 2019
FDA draft guidance for industry entitled “Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.”
10th September 2019
FDA draft guidance for industry entitled “Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy.”

FDA draft guidance for industry entitled “Population Pharmacokinetics.”

16th September 2019
FDA draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Revision 7).”

FDA draft guidance for industry entitled “Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues.”

25th September 2019
FDA draft guidance for industry entitled “E19 Optimisation of Safety Data Collection.”

FDA draft guidance for industry entitled “M10 Bioanalytical Method Validation.”

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.

FDA draft guidance for industry entitled “Rare Pediatric Disease Priority Review Vouchers.”

FDA draft guidance for industry entitled “Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers.”

FDA draft guidance for industry entitled “E8(R1) General Considerations for Clinical Studies.”

9th October 2019
FDA draft guidance for industry entitled “Using the Inactive Ingredient Database.”
15th October 2019
FDA draft guidance for industry entitled “Gastroparesis: Clinical Evaluation of Drugs for Treatment.”
30th October 2019
FDA draft guidance for industry entitled “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.”
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.
6th November 2019
FDA draft guidance for industry entitled “Fabry Disease: Developing Drugs for Treatment.”