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Goodwin

FDA to Hold Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act

Goodwin on

Tomorrow, March, 22, 2022, the FDA will host a public meeting entitled “Final Assessment of the Program for Enhanced Review Transparency and Communication in in the Biosimilar User Fee Act.” As part of the Biosimilar User Fee...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

McDermott Will & Emery

FDA Hosts Public Meeting on Off-Label Communications

McDermott Will & Emery on

The US Food and Drug Administration (FDA) recently held a two-day public meeting on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (off-label communications), which offered...more

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