News & Analysis as of

Manufacturers Public Hearing

Troutman Pepper

California Considers Modifying Prop 65 Warning Requirements (Again)

Troutman Pepper on

In 2021 we wrote about the California Office of Environmental Health Hazard Assessment’s (OEHHA) plans to amend regulations governing Proposition 65 (Prop 65) short-form warning labels. On May 20, 2022, however, OEHHA...more

Holland & Knight LLP

FDA Issues Statement on Cannabis Regulation and Announces Public Hearing

Holland & Knight LLP on

On April 2, 2019, FDA outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction...more

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

Schwabe, Williamson & Wyatt PC

Public Hearing Set for Amended Overtime Statutes

Manufacturers who will be affected by the new changes to the overtime rules may be interested in attending a public hearing and/or providing public comment on the development of the Oregon Administrative Rules that BOLI will...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

Goodwin

FDA Call For Comments on Off-Label Communications

Goodwin on

The FDA has announced a 2-day public hearing related to communications by manufacturers, packers, and distributors, regarding, in part, drugs licensed as biological products. There will be a particular focus on communications...more

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