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Latest From Review Pathway

Pink Sheet Podcast: US FDA Launches Project Orbis And The Rare Disease Cures Accelerator, Looks For Abuse-Deterrent CNS Drugs

Pink Sheet reporters discuss the US FDA's work with other countries to review and approval of cancer therapies at the same time, a new database for rare disease clinical trial and natural history data, and the agency's exploration of abuse-deterrent CNS stimulants.

Drug Review Rare Diseases

Senate Wants Priority Review For 'Deemed' Biologics Not Approved By Deadline

Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.

Biologics Legislation

Pain/Addiction Products Need Regulatory Streamlining To Incentivize Development, Sponsors Say

Industry speakers offer series of suggestions for ways to incentivize development of pain and addiction products at US FDA public meeting on the opioid crisis.

Review Pathway Research & Development

US FDA’s Project Orbis Could Streamline Global Clinical Trials In Cancer

Richard Pazdur tells the Pink Sheet that program for concurrent submission of oncology applications and collaborative review by global regulators also could speed approval in smaller countries; first applications under Project Orbis were for use of Lenvima/Keytruda combination for endometrial cancer in US, Canada, and Australia.

Drug Review Review Pathway

US FDA Struggles To Meet Goals As Drug Sponsors' Meeting Requests Rise

The FDA did not expect to meet many FY 2018 goals for on-time scheduling of formal PDUFA meetings or issuing written responses in lieu of meetings.

Review Pathway FDA

The New Payer Dogma: US FDA Approved Drugs Have 'Less Evidence'

It is now a common assertion among insurers that one of the many challenges they face in covering high-priced specialty therapies is that drugs are approved with “less evidence” than used to be the case. That is more myth than reality – but a very dangerous myth if it isn’t corrected by the US FDA and the drug industry.

Drug Approval Standards Pricing Debate

Everything's Special At US FDA: Priority NDA/BLA Filings Surge

The FY 2018 PDUFA performance report also indicates that applications with standard assessments fell compared to long-term averages.

Drug Review Regulation

Mustang Bio Joins RMAT List; Eiger Brings Home Its 4th BTD

Gene therapy and lambda interferon products are highlighted in the new Review Pathways section of the US FDA Performance Tracker, which keeps track of breakthrough therapy (BTD), regenerative medicine advanced therapy (RMAT), qualified infectious disease product (QIDP) designations and biosimilar submissions.

Rare Diseases Review Pathway

Mesoblast Sees Accelerated Path To Market For Revascor In Sickest Heart Failure Patients

US FDA agrees to plan to seek approval for ‘off the shelf’ cell therapy with Phase II data showing fewer major mucosal bleeding events in end-stage heart failure patients implanted with mechanical assist devices; confirmatory Phase III is set to begin this year.

Drug Approval Standards Cardiovascular
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