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User Fees: Should US FDA Incur Penalties For Missed Deadlines?

Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.

Approvals FDA

India Eases Approval Process For HIV, Hepatitis Combinations

India has outlined measures to fast track the regulatory process for certain combination products for HIV and hepatitis, and thereby facilitate early access to these treatments.

Review Pathway Infectious Diseases

Combo Products Won't Get Special Review Pathway At US FDA Anytime Soon

Jeffrey Shuren and Janet Woodcock tell Senate committee that agency is more concerned with implementing combination product provisions of the 21st Century Cures Act.

Combination Products Review Pathway

Australian Provisional Approval Pathway To Get Tough On Sponsors Upfront

Plans by Australia’s Therapeutic Goods Administration to develop a provision approval pathway for drugs have moved up a gear.

Review Pathway Market Access

Now Is The Time! Rule Changes To Smooth China New Drug Approvals?

The China FDA has outlined a raft of new measures to streamline the development and approval process for foreign new drugs, in changes that are likely to quicken the pace of launches to potentially overcome China’s “drug lag” and that may also bolster multinationals’ interest and activity in the country.

China Regulation

Keeping Track: US FDA Accepts Ertugliflozin, Extends Reviews Of Abaloparatide, New Keytruda Claim

The latest drug development news and highlights from our FDA Performance Tracker.

Approvals Review Pathway

Combination Product Designations At US FDA Need Faster Appeals, Petition Says

No sponsor is named in the citizen petition, but it was filed on behalf of an applicant that has had an appeal of a designation decision 'under consideration' for 18 months and counting.

Review Pathway Combination Products

Novel US FDA Approvals Could Rebound In 2017: 40+ Candidates Already Under Review

Novel approvals by US FDA in 2017 could easily surpass the 28 agents approved by the agency's drug and biologics centers in 2016. The big question is whether last year's spike in complete response letters was an anomaly or the start of a trend.

Approvals Review Pathway

EU Decentralized Procedure Pilot Seeks To Speed Up Validations

All marketing approval applications submitted via Europe’s decentralized procedure are being processed under a new pilot that should help regulators validate applications faster. The pilot might also give companies a better understanding of the validation process and how omissions or mistakes in their documentation might invalidate or delay their applications.

Review Pathway Drug Review
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