Regulatory Guidance Review - April 2019

Latest Updates from FDA & EMA

April 2019 Updates

Veristat's March 2019 Review of FDA Regulatory Guidances and EMA updatesEach month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  and European Medicines Agency (EMA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval.   Below are the relevant links to updates provided in April 2019.


FDA Updates

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FDA has Finalized the Following Draft Guidance Documents:


REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary (Issued on 04Apr2019)


Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling Guidance for Industry (Issued on 27Mar2019)


Pediatric HIV Infection: Drug Product Development for Treatment (Issued on 19Mar2019)


Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis Guidance for Industry (Issued on 19Mar2019)


FDA has Issued the Following New Draft Guidance Documents:

Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes Guidance for Industry (Issued April 2019)


Compliance Policy for Combination Product Postmarketing Safety Reporting (Issued April 2019)

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 FDA In The News: 

The Office of Management and Budget will begin enforcing the Congressional Review Act (CRA) of 1996.  OMB intends to review all guidance that can be considered “major”.

Minimal Residual Disease as a Surrogate Endpoint for Product Development for Multiple Myeloma: Comparing FDA and EMA Guidances (Published on 08Apr2019)


Patient Groups, Industry Seek Changes to Rare Disease Drug Guidance (Published 04Apr2019)


Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs (Published on 03Apr2019)


Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward (Published on 29Mar2019)


CDER Reorganization to Go Live on March 31, 2019


EMA Updates


MHRA Offers No-Deal Guidance on Pharmaceutical Product Certificates (Published 08Apr2019)


1.7% increase of fees payable to EMA from 1 April 2019 (Published 01Apr2019)