Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA User Fees

Set Alert for FDA User Fees

Worries About 180-Day Exclusivity Reforms Persist As User Fee Bill Advances

FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.

Generic Drugs Legislation

Inter-Agency User Fees? US FDA/ARPA-H Relationship Could Get Interesting

The Biden Administration’s signature health research agency ARPA-H is still in the formative stages. Authorizing legislation moving through Congress could set up a very interesting dynamic when it comes to working with the US FDA.

FDA Research & Development

New Zealand Hikes Fees To Reflect Changes In Drug Applications

Following a consultation last year, Medsafe has set new fee levels that take account of both cost-recovery principles and a 4.2% increase in the consumer price index. 

New Zealand Drug Review

US FDA Could Require Pediatric Cancer Drug Combo Studies Under Amended User Fee Bill

House Energy & Commerce Committee adds Give Kids a Chance Act to user fee reauthorization package during markup. Bill was modified to exclude provision giving the FDA authority to require preclinical studies.

Clinical Trials Pediatrics

House User Fee Mark-Up: Few Tweaks, But Concerns About ALS And Accelerated Approval

Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.

User Fees Legislation

Accelerated Approval, Clinical Trial Diversity Provisions Left Out Of Senate User Fee Bill

Two of the most prominent features of the House package are not addressed in the Senate measure, which predominantly focuses on cosmetics, dietary supplements and laboratory developed tests. The absence of competing proposals suggests a smooth conference process.

User Fees FDA

Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions

The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.

Biosimilars User Fees

Pink Sheet Podcast: FDA User Fee Bill Mark-Up, Postmarket Quality Requirements, Fewer Adcom Meetings

Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.

Legislation Manufacturing

Bullet Train: US FDA User Fee Bill Is On Fast Track In House

The House Energy & Commerce Committee is moving rapidly to complete work on a bipartisan reauthorization of the US FDA’s user fee programs – and it isn’t waiting for any riders that aren’t ready on time. For now, at least, that means the CURES 2.0 bill will have to find another track.

User Fees Legislation

Patient Data In Drug Reviews Would Be Encouraged In Proposed Amendment To User Fee Bill

Rep. Matsui withdrew amendment on FDA’s use of patient experience data during health subcommittee markup of user fee reauthorization legislation, but it may be considered in full committee markup following agency input. Chair Eshoo says the provision specifying contrast agents must be regulated as drugs needs to be reworked to include ophthalmic products.

FDA User Fees

Inactive Ingredient Disclosure Expansion In House User Fee Bill Poised For Changes

Republicans share brand industry worry about disclosure of confidential commercial information, suggesting changes may be possible during the upcoming full committee bill mark-up.

Generic Drugs User Fees

Preapproval Information Exchange Between Sponsors, Insurers Clarified In House User Fee Bill

By codifying FDA guidance, pending legislation aims to encourage industry to become more comfortable with even unsolicited communications to payers about investigational drugs.

Advertising, Marketing & Sales Reimbursement
See All
UsernamePublicRestriction

Register