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OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion Draft

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

Consumer Consumer

Two-Tier OTC Monograph Approach Could Come With User Fee Revamp

One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate discussion draft. Essentially stalled monograph process would be replaced by deadlines for FDA action in under two years.

Consumer Legislation

Tweaked ‘New Drugs’ Flouted Price Approval Norms In India

Pharmaceutical firms face more flak in India for allegedly flouting pricing norms – this time more than 200 formulations were allegedly launched in the country without seeking price approvals, though some companies claim they are fully compliant with the norms.

Regulation India

Breakthrough-Style Program For ANDAs Added To House User Fee Bill

Energy and Commerce subcommittee unanimously advances reauthorization legislation with four added amendments, including one that would allow for certain generic sponsors to meet early and often with FDA to speed development.

Generic Drugs Legislation

Off-Label Discussion, But No Additions, For House User Fee Bill

Several Republicans remain interested in expanding off-label communications, suggesting the issue could come up outside the user fee context, potentially as part of future drug pricing discussions.

United States Advertising, Marketing & Sales

Robert Califf Talks Verily, Hopes Gottlieb Can Push Back On Trump

Former US FDA Commissioner is joining the health-technology firm Verily, a Google spin off. In a podcast interview he discusses his new advisory role with the company and expresses his hope that new FDA Commissioner Scott Gottlieb would stand up to any 'whimsical directives' from President Trump.

FDA Legislation
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