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Latest From Review Pathway

December ANDA Rush Is Largest Monthly Haul In Two Years

However, the month may be losing its influence over the US FDA's annual submission total.

Generic Drugs Review Pathway

Sharfstein: US FDA Incentives Not Broke, But Fix Them

The former US FDA principal deputy commissioner argues that accelerated approval, fast track and breakthrough designation standards may need updating, along with orphan and pediatric exclusivity requirements, to enhance the programs' efficacy.
Drug Review Research and Development Strategies

EU Biosimilar Filings, Opinions And Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Europe European Performance Tracker

Keeping Track: Year-End Submissions Rush Brings Seven Novel Agents To US FDA

Highlights of year-end application submissions including candidates from AstraZeneca, BioMarin, Lilly, MorphoSys, and Seattle Genetics.

Drug Review Review Pathway

More Talk, Less Work: US FDA Outlines Expectations For Combo Products Discussions

New FDA draft guidance says manufacturers of combination products should first review existing combination product guidances and submit questions before asking for a combination product agreement meeting with regulators to get clarification. The guidance outlines what is expected of both sides in such meetings.

Regulation FDA

Calls to End Industry’s ‘Financial Entanglement’ With Healthcare Players

Financial ties between companies and healthcare bodies distort the production and use of evidence, claims a paper co-authored by researchers, clinicians and decision makers, including a representative of Germany’s HTA body, IQWiG.

Europe Germany

US FDA Pushes Back Against Critics: Breakthrough Is Not A Drug 'Beauty Contest'

Richard Pazdur, FDA's oncology chief, reiterates the breakthrough therapy designation is for agency-sponsor communication and not an investor tool.

Drug Review FDA

ANDA Approval Records Will End As US FDA Mops Up Backlog

CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.

Generic Drugs Review Pathway

Lynparza, Keytruda Supplemental Indications Face US FDA Panel Review

AstraZeneca and Merck seek to add a pancreatic cancer indication for olaparib, while Merck has hopes of broadening pembrolizumab’s use in bladder cancer; two-day Oncologic Drugs Advisory Committee meeting also will include reviews of Celgene’s luspatercept in myelodysplastic syndromes-related anemia and Epizyme’s tazemetostat for epithelioid sarcoma.

Advisory Committees Drug Review
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