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Akin Gump Strauss Hauer & Feld LLP

FDA Announces Quality Metrics Pilot Programs

Akin Gump Strauss Hauer & Feld LLP on

• FDA has announced new quality metrics pilot programs that seek industry stakeholder perspective and feedback. • FDA’s voluntary pilot programs target companies submitting Type C and Pre-ANDA meeting requests, as well as...more

Verrill

"Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now

Verrill on

On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more

Mintz - Consumer Product Safety Viewpoints

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

Mintz - Consumer Product Safety Viewpoints on

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter...more

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