Data Collection, Pharmaceutical Industry, Draft Guidance

FDA updates 2016 guidance on the collection of race and ethnicity data

Hogan Lovells on 2/19/2024

The U.S. Food and Drug Administration (FDA) continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document entitled, “Collection of Race and Ethnicity...more

FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials

King & Spalding on 8/25/2023

The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more

FDA sheds light on benefit-risk assessments to inform decision-making throughout product lifecycle - Patient experience data can...

Hogan Lovells on 10/18/2021

The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare...

Hogan Lovells on 1/23/2019

On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are...more

China Drug Administration publishes a key Draft Guidance on data exclusivity

Hogan Lovells on 5/8/2018

This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more

Data Collection › Pharmaceutical Industry › Draft Guidance

FDA updates 2016 guidance on the collection of race and ethnicity data

FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials

FDA sheds light on benefit-risk assessments to inform decision-making throughout product lifecycle - Patient experience data can...

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare...

China Drug Administration publishes a key Draft Guidance on data exclusivity

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