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Latest News & Analysis

Expanded Access Data Can Support Approval Decisions, US FDA Says

Formal reg not needed, according to agency; officials agree that regulatory flexibility is best way to offer sponsors advice, saying data collected during compassionate use can be helpful in guiding regulatory decisions. 
Clinical Trials Review Pathway

Unlicensed Stem Cell Clinics Are 'Surrogate' For Right To Try, US FDA's Marks Says

CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try.
Drug Safety Clinical Trials

Keeping Track Of Immuno-Oncology: An Updated Guide To Applications At FDA

Infographic highlights products in the burgeoning PD-1/L1 checkpoint inhibitor class either approved or under review, from the Pink Sheet's FDA Performance Tracker. 
 
Cancer Approvals

Acthar Proposed Giveaway Program Raises Kickback Concerns, OIG Says

High price of Mallinckrodt’s H.P. Acthar Gel is important factor in conclusion, HHS Office of Inspector General advisory opinion notes.

Pricing Debate Medicaid

US FDA Office Of New Drugs Likely To Be Headed By Deputy Director Stein

Peter Stein is a familiar face within OND and has been working alongside CDER Director Janet Woodcock on the proposed “modernization” of OND. As a previous recruit from outside FDA, Stein has had time to make the key connections and adjustments to working inside government.
FDA Leadership

UK Agency Boss Hudson Leaves Brexit Challenge To Successor

A new leader is needed for MHRA as UK agency CEO Ian Hudson announces he'll leave next September. Someone else will have to reshape and guide the agency after Brexit.
Europe Brexit

European CHMP Opinions And MAA Updates

This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Drug Review Europe

French Launch Fast-Track Clinical Trial Approval Scheme

Sponsors are being invited to trial a new fast-track system for authorizing clinical trials as part of French preparations for the new EU trial rules that are set to come into force in 2020.

Clinical Trials France

Pain Therapeutics Appeals Remoxy CRL In Likely Last Ditch Effort To Save Abuse-Deterrent Opioid

Meeting with US FDA in January will aim to reverse fourth rejection in 10 years; firm still criticizing agency even as it works to reconcile their positions.
Complete Response Letters Neurology

Drug/Software Combos Likely Won't Require Pre-Market Review By US FDA

But sponsors should sometimes seek advisory comment. Agency explains that most drug-use-related apps will be considered promotional labeling. FDA seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-focused software.

Digital Health Advertising, Marketing & Sales

US FDA Launches Study Of Prescriber Perceptions About Abuse-Deterrent Opioids

The agency is assessing whether to use different language to describe addiction and abuse deterrence.
Drug Safety Neurology

Gene Therapy Guidance From US FDA Likely Needs Updating Sooner Rather Than Later

CBER Director Peter Marks says the "half-life" for the existing six gene therapy guidances likely is two to three years due to the fast pace of scientific discovery.
Regenerative Medicine Regulation
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