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Right-To-Try Bill Heads To White House, Putting Firms In Driver's Seat

Proponent says companies ready to use new expanded access pathway that US FDA will have essentially no involvement in.
Legislation Clinical Trials

House Appropriators Warn US FDA: Stop Working On Electronic Labeling Rule

Congress is 'very concerned' about potential final rule that would move to electronic labeling in lieu of paper distribution with prescriptions.
FDA Legislation

Ahead Of Speech, Democrats Skeptical About Trump Drug Pricing Plans

US House members and Center for American Progress urge policies that directly target drug pricing practices and not only patient cost sharing.

Pricing Debate Legislation

OTC Monograph Reform Could ‘Unlock’ Innovations In Three Years

Following enactment of US OTC monograph reform, drug companies will unleash formulation innovations after keeping a lid on monograph R&D, CHPA anticipates. "A lot of companies have ideas like this they’ve kind of put in a drawer, that we think this is gonna unlock,” says David Spangler, an executive with the OTC trade group.

Consumer Legislation

OTC Monograph Legislation Clears Another Hurdle Despite Exclusivity Concerns

Democrats' opposition to the length of the exclusivity allowed for some new monograph products didn't stop them from voting to send US OTC monograph overhaul legislation on for a vote by the full House. House/Senate differences and some members' questions on whether new exclusivity is needed could make it harder for reforms to pass this year.

Consumer Legislation

EMA And Dutch Govt Eye July Signing Of Deal To Move Agency To Amsterdam

The EMA and the Dutch authorities are expected to sign the agreement on the agency’s new home in Amsterdam on July 1. The agreement is aimed at ensuring the agency can function properly once it relocates, and describes how the Dutch government will treat the agency and its staff.

Brexit Europe
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