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First Amendment Public Hearing

The First Amendment to the United States Constitution prohibits the government from making laws respecting the establishment of religion, prohibiting the free exercise of religion, abridging the freedom of speech... more +
The First Amendment to the United States Constitution prohibits the government from making laws respecting the establishment of religion, prohibiting the free exercise of religion, abridging the freedom of speech or the press, preventing citizens from peacefully assembling, or interfering with citizens' ability to petition the government for redress of their grievances. The First Amendment is one of the most sacred aspects of the American legal tradition and has spawned a vast body of jurisprudence and commentary. less -
Hogan Lovells

California accelerates towards GHG Disclosures in advance of 2026 Deadlines with Regulatory Timeline and Litigation Win (SB 253...

Hogan Lovells on

The California Air Resources Board (CARB) is forging ahead in implementing what the Agency now refers to as “the 200s”—the Climate Corporate Data Accountability Act (SB 253) and the Climate Related Financial Risk Act (SB...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

Best Best & Krieger LLP

Officials’ Top 10 Things to Remember About Public Participation in Local Government

As the national political climate heated up recently, some local governments are facing spillover effects, with local and sometimes even out-of-town activists and provocateurs attending city council, school board and other...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 & Schulte

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

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

Mintz - Health Care Viewpoints

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

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