6th April 2020
FDA draft guidance for industry entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products—Questions and Answers.”
7th April 2020
FDA draft guidance for industry entitled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”
7th April 2020
EMA Scientific guideline: Reflection paper on good manufacturing practice and marketing authorisation holders, draft: consultation open.
20th April 2020
FDA draft guidance entitled “Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics.”
30th April 2020
EMA Scientific guideline: CVMP reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU, draft: consultation open.
5th May 2020
FDA draft guidance for industry entitled “Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment.”
20th May 2020
European Commission second targeted stakeholders’ consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4.