Consultation Deadlines

Home  /  Consultation Deadlines
20th December 2019
PIC/S revised draft GMP Guide Annex 2A (Manufacture of Advanced Therapy Medicinal Products for Human Use) and Annex 2B (Manufacture of Biological Medicinal Substances and Products for Human Use).

FDA draft guidance for industry entitled “Drug Master Files.”

24th December 2019
FDA draft guidance for industry entitled “Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.”
30th December 2019
FDA draft guidance for industry, FDA staff, and other stakeholders entitled “Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.”

FDA draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.”

31st December 2019
FDA draft guidance for industry entitled “Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.”
23rd January 2020
FDA revised draft guidance for FDA staff and industry entitled “Drug Products Labeled as Homeopathic.”
7th February 2020
FDA draft guidance for industry entitled “Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids.”
19th February 2020
FDA draft guidance for industry entitled “Transdermal and Topical Delivery Systems—Product Development and Quality Considerations.”
2nd March 2020
FDA draft guidance for industry entitled “Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment.”
30th April 2020
EMA Scientific guideline: CVMP reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU, draft: consultation open.