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Column: Regulatory Spotlight
The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative
PAO-06-022--NI-05
Column: Regulatory Spotlight
New FDA Guidance on Real World Evidence/Real World Data
PAO-03-022-NI-03
COVID-19
Regulating Clinical Trials in Pandemic Times
PAP-Q2-20-NI-005
FDA Guidance
Updating Ethical Guidelines for Cancer Clinical Trials
PAP-Q3-19-NI-006
Clinical Trials
FDA Provides Guidance on Increasing Clinical Trial Diversity
PAO-M07-19-NI-003
FDA
FDA Issues Draft Guidance for Companion Diagnostics
PAO-M12-18-NI-009
FDA Guidance
FDA Published Draft Guidance on Use of Placebo Control Groups
PAO-M08-18-NI-029
FDA
FDA Announces Policies to Facilitate Development of Generic Drugs
PAO-M06-18-NI-004
FDA Guidance
FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
PR-M04-18-NI-54
FDA
Kadmon Receives FDA Guidance on Pivotal Clinical Trial Design for KD025 in Chronic Graft-Versus-Host Disease
PR-M04-18-NI-46
FDA
FDA Removes Expired Drug Establishment Registrations and Uncertified Listings from its Database
PR-M01-18-NI-017
FDA Guidance
FDA Received Numerous Comments on Its Draft Guidance for Evaluating Biosimilarity
PAO-M01-18-NI-004
FDA
New FDA Draft Guidance Intended to Accelerate Development of Drugs for Rare Pediatric Diseases
PAO-M12-17-NI-023
FDA
FDA Finalizes Emerging Drug Manufacturing Technology Guidance
PAO-M10-17-NI-012
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