An FDA memo outlining restrictions on communications over unapproved uses could restrict the flow of important information, and conflict with a company’s freedom of speech, say drugmakers and industry groups.…

Drugmakers said the FDA’s draft guidance on off-label communications is a good start, but needs clearer language. Source: Drug Industry Daily

Drugmakers are urging the FDA to revise draft guidance on the intended audiences for industry communications. Source: Drug Industry Daily

CDER updated its guidance agenda for 2017, adding an item on Gaucher Disease. Source: Drug Industry Daily

The FDA has cited contract manufacturer Aesica for quality and record-keeping problems. Source: Drug Industry Daily

The EMA is planning to focus on 13 separate initiatives for 2017, ranging from fully implementing its priority medicines review pathway to boosting international cooperation. Source: Drug Industry Daily

A California prosecutor is suing Boehringer Ingelheim and a Teva subsidiary, saying their $120 million agreement to push back the release of a generic Aggrenox blood thinner illegally delayed market…

The Senate health committee has scheduled its vote on the nomination of Scott Gottlieb to be the next commissioner of the FDA — for April 26. Source: Drug Industry Daily

The U.K.’s Medicines and Healthcare products Regulatory Agency is finding more sterility assurance violations during facility inspections. Source: Drug Industry Daily

Drugmakers are increasingly using joint ventures and research consortia to accelerate early stages of drug development and share the burden of cost, according to Deloitte. Source: Drug Industry Daily