Consultation Deadlines

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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FDA draft guidance for industry entitled “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.”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FDA draft guidance for industry entitled “Fabry Disease: Developing Drugs for Treatment.”
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FDA draft guidance for industry entitled “Drug Master Files.”

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FDA draft guidance for industry, FDA staff, and other stakeholders entitled “Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.”
30th April 2020
EMA Scientific guideline: CVMP reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU, draft: consultation open.