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Katten Muchin Rosenman LLP

Fast-Lane Approval to Boost U.S. Drug Manufacturing and Supply Chain Security

On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based...more

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

WilmerHale

FTC’s Second Open Commission Meeting Continues to Highlight Competition Agenda

WilmerHale on

On July 21, 2021, the Federal Trade Commission (“FTC” or “Commission”) held its second Open Commission Meeting. There were three items on the agenda: (1) whether or not to rescind a 1995 policy statement on prior approval and...more

Hogan Lovells

Proposed rule seeks to significantly strengthen U.S. Government “Buy American” requirements

Hogan Lovells on

On 30 July 2021, the FAR Council published a proposed rule to significantly strengthen “Buy American” requirements applicable to goods sold to the U.S. Government. The proposed rule promotes the procurement of goods,...more

ArentFox Schiff

Alerts Newsletter: This California Warning Might Cause Alarm – or Apathy

ArentFox Schiff on

The discussion about including the most commonly used drug in the US has once again raised questions about the value of Proposition 65 warnings to consumers. Environmental advocates say the law has compelled companies to...more

Mintz - Consumer Product Safety Viewpoints

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

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 & Schulte

FDA Hosts Public Meeting on Off-Label Communications

McDermott Will & Schulte 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

Latham & Watkins LLP

No Small Issue: EPA’s Proposed Rule for Nanoscale Material Reporting

Latham & Watkins LLP on

Arguably necessary and long overdue, but not without issues and challenges. Introduction - On March 25, 2015, the U.S. Environmental Protection Agency (EPA or the Agency) issued a Proposed Nanoscale Material...more

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