2013, Food and Drug Administration, Networking and Safety

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2013

Food and Drug Administration

Networking

Safety

Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Another benefit is that fewer patients are required in clinical trials using HCs, thereby reducing time to trial completion and speeding drug approval. Patel et al.

Food and Drug Administration

Food and Drug Administration Patients Distribution FDA

Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.

Pharmaceutical

Pharmaceutical Food and Drug Administration Manufacturing FDA

Pharma Rep Focus

Using RWE in rare disease drug development: effective innovations with historical controls

Pharmaceutical microbiology: key developments 2022

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