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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

ANDA User Fee Misses Are Mostly Part Of 'Imminent Approval' Process

US FDA will miss goal dates to reach speedier generic drug application approvals, but says decisions will be case by case.

Review Pathway Generic Drugs

Antibiotics: Leveraging Off-Label Efficacy Data Needed To Drive Appropriate Use, Reimbursement

Clinicians and sponsors want the US FDA to open up antibacterial labeling to include more data on efficacy against resistant pathogens and in other body sites, but regulatory restrictions may require a workaround in the form of rapid, peer-to-peer communications about the data on new products.

Advertising, Marketing & Sales Reimbursement

Complex Generics May Need New Communications Options In GDUFA III

US FDA and complex generic sponsors need a way to talk about reference product and other changes once the pre-submission meetings pathway is exhausted.

Generic Drugs Drug Review

Pink Sheet Podcast: US FDA Commissioner Nominee Stephen Hahn Appears Before The Senate, Controversial Regulations In The New Unified Agenda

Pink Sheet reporters explain Stephen Hahn's responses to Senators' questions and discuss some of the new regulations that FDA plans to release in the coming months.
FDA Leadership

Generic Drug Approvals In US Off To Slow Start In FY 2020

US FDA reports another low tally of full approvals in October, but stakeholders are not worried given the agency's history of record-breaking totals year over year.

Generic Drugs Review Pathway

New Tech Payment For Old Antibiotics: US Medicare Effort Brings Lots Of Interest

CMS streamlined process for enhanced payments is having an impact: seven antibiotic applications for New Technology Add-On Payment status in 2021—including one for a product that has been marketed for more than five years.

Infectious Diseases Reimbursement
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