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US Combo Product Designation Appeal Process Limited In Proposed Rule

Overhaul of reg on how combo products are designated to review centers eliminates the reconsideration appeal, but US FDA still allows appeals up the chain of command.

Combination Products Review Pathway

Orphan Designations For Cancer Drugs: US FDA Urged To Distinguish Tissue-Agnostic From Tumor-Specific Diseases

Generic and brand firms both seem to want ‘very black and white lines’ on orphan exclusivity, but FDA isn't so sure how to distinguish biomarker-targeted disease from histologically-defined disease.

Rare Diseases Review Pathway

Gottlieb On Gene Therapies: 'Very Seductive' To Think About Accelerated Approval Pathway

Accelerated approval would help agency monitor gene therapies for durability and off-target effects, US FDA commissioner says.

Review Pathway Regulation

Goal Date Confusion: The Downside Of Generic Drug Assessment Transparency

ANDA sponsors worry launch plans cannot be finalized if US FDA will not inform them whether their application requires a facility inspection.
Generic Drugs Manufacturing

Plazomicin's BSI Indication Could Be First LPAD Drug – If Achaogen Can Convince US FDA Of Efficacy

Advisory committee will review applications for cUTI indication, which looks good, and the BSI indication, which looks fraught.
Advisory Committees Infectious Diseases

Priority Review Voucher Crash: Spark's Sale To Jazz Lowest Price Since 2014

Only the first publicly disclosed sale of a priority review voucher was lower than what Jazz Pharmaceuticals paid Spark Therapeutics for its coupon.
Rare Diseases Review Pathway

WHO Still Planning Biosimilar Naming Guidance, Gives Update On Prequalification Pilot

Despite putting it on hold last year, the World Health Organization is keeping its idea of biosimilar naming guidance alive. And at a recent conference it updated delegates on the pilot project for prequalifying biosimilar versions of infliximab and trastuzumab.

Biosimilars Regulation

SIGA’s Smallpox Drug Tecovirimat Looks Primed For Smooth US FDA Panel Review

Although not tested in smallpox animal models, tecovirimat demonstrated efficacy in surrogate orthopoxvirus disease models in non-human primates and rabbits, FDA says; SIGA seeks approval under the 'Animal Rule' for a broad population of adult and pediatric patients, but agency notes drug's safety has not been clinically tested in children and other vulnerable populations.

Advisory Committees Review Pathway

No Safety Shortcuts Under Breakthrough Designation, Synthetic Biologics Finds

Synthetic Biologics emerged from meetings with US FDA without its breakthrough designation, but with hope that agency will allow decoupling of safety and efficacy endpoints in planned Phase III trial for prevention of C. difficile infection.
Drug Approval Standards Drug Safety
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