Column: Regulatory Spotlight

The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative

David Alvaro, Ph.D.

Pharma's Almanac

Column: Regulatory Spotlight

New FDA Guidance on Real World Evidence/Real World Data

David Alvaro, Ph.D.

Pharma's Almanac

COVID-19

Regulating Clinical Trials in Pandemic Times

David Alvaro, Ph.D.

Pharma's Almanac

FDA Guidance

Updating Ethical Guidelines for Cancer Clinical Trials

David Alvaro, Ph.D.

Pharma's Almanac

Clinical Trials

FDA Provides Guidance on Increasing Clinical Trial Diversity

Emilie Branch

Pharma's Almanac

FDA

FDA Issues Draft Guidance for Companion Diagnostics

Cynthia A. Challener, Ph.D.

Pharma's Almanac

FDA Guidance

FDA Published Draft Guidance on Use of Placebo Control Groups

Emilie Branch

Pharma's Almanac

FDA

FDA Announces Policies to Facilitate Development of Generic Drugs

Emilie Branch

Pharma's Almanac

FDA Guidance

FDA Received Numerous Comments on Its Draft Guidance for Evaluating Biosimilarity

Nice Insight

FDA

New FDA Draft Guidance Intended to Accelerate Development of Drugs for Rare Pediatric Diseases

Nigel Walker

Nice Insight

FDA

FDA Finalizes Emerging Drug Manufacturing Technology Guidance

Nigel Walker

Nice Insight