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Featured Stories



MHRA Chief On How The UK Agency Is Overhauling Its Processes To Overcome Post-Brexit Challenges

The Medicines and Healthcare products Regulatory Agency has introduced a series of changes, including an upcoming overhaul of its clinical trial legislation, to enhance its performance in the future, chief executive Dame June Raine writes.

Regulation United Kingdom Clinical Trials

EU Pharma Reform Amendments: More Shortage Reporting Obligations For Companies & Regulators

In the third of a series of articles on the European Parliament’s changes to the planned reform of EU pharmaceutical legislation, the Pink Sheet looks at how the amended proposals on notifying drug shortages could impact companies, regulators and wholesale distributors.

Europe EU Legislative Reform Regulation

FTC Is Taking A Tougher Stance On Pharma, A Deputy Director Explains Why

Rahul Rao, the deputy director of the FTC Bureau of Competition, discussed the agency’s thinking on recent pharma deals that it viewed as anti-competitive.

Deals Enforcement Policy

Califf On Capitol Hill

US FDA's Califf Defends Agency Work On Marijuana Rescheduling, Animal Testing

House appropriations subcommittee chair Andy Harris, R-MD, says the agency ignored several important factors in recommending that marijuana be reclassified as a Schedule III drug; Califf tells ranking member Sanford Bishop, D-GA, that although work is progressing on animal testing alternatives, 'we're a long way right now' from eliminating animal studies before first-in-human trials.

Cannabidiol CBD Research & Development

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Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

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PTC’s Upstaza Takes Gene Therapy Straight To Brain (And US FDA); Translarna To Return Mid-Year

In a year full of regulatory milestones for the firm, PTC Therapeutics hopes to set some approval precedents – and basically hopes its candidates have an easier time of it than they have had before.

US FDA Performance Tracker Gene Therapy Drug Approval Standards

Global Pharma Guidance Tracker – April 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation International


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