Regulatory Guidance Review

Latest Updates from FDA & EMA

March 2019

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 March 2019.


FDA Updates


FDA has finalized the following guidance documents:

Considerations for the Inclusion of Adolescent Patients in Adult Oncology Trials (finalized 03/12/2019)


Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (finalized 03/14/19)


Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals (finalized 03/14/19)


Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research (finalized March 2019)


FDA has issued the following new draft guidance documents:

Bioavailability Studies Submitted in NDAs or INDs – General Considerations (issued 02/25/19)


Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations (02/25/19)


Quality Considerations for Continuous Manufacturing (issued 02/26/19)


Cancer Clinical Trial Eligibility Criteria: Brain Metastases (issued 03/12/19)


Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies (03/12/19)


Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients (03/12/19)


Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections (03/12/19)


A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers (03/14/19)

  • This is an expansion of the 2013 guidance “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring”; it does not replace the 2013 guidance.


Rare Diseases: Natural History Studies for Drug Development (03/22/19)


Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling (03/27/19)


FDA In The News:


Statement from FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development (03/14/19)


EMA Updates:


EMA has published a questions-and-answers (Q&A) document on the preparatory work that European Union authorities are doing to prevent medicine shortages due to the United Kingdom’s withdrawal from the EU. (03/26/19)


As of today, EMA is operating from Amsterdam (03/11/19)


New EudraVigilance system improves reporting of side effects and detection of safety signals (03/27/19)