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Manufacturers Pharmaceutical Industry Public Hearing

Hogan Lovells

FDA schedules public hearing on solutions to drug shortages

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has announced it will hold a public meeting on November 27 in Washington, D.C. to give stakeholders – including health care providers, patients, manufacturers, wholesalers,...more

Wilson Sonsini Goodrich & Rosati

FDA Holds Hearing on Off-Label Communications

After several high-profile defeats in both district and circuit courts involving the off-label promotion of regulated products and the First Amendment, the U.S. Food and Drug Administration (FDA) is now engaged in a...more

Mintz - Health Care Viewpoints

Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more

McDermott Will & Emery

FDA Announces Public Hearing on Off-Label Communications; Registration Deadline October 19, 2016

McDermott Will & Emery on

The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label...more

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