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Publications

Hogan Lovells Podcasts

Podcast: Talking the cure

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting-edge topics such as...

News

FDA issues final guidance for importing drugs prior to anticipated approval

Last week, the U.S. Food and Drug Administration (FDA) published the final guidance, “Pre-Launch Activities Importation Requests (PLAIR),” describing its policy regarding...

News

New FDA proposed rule will eventually preempt state drug wholesaler/3PL licensure laws

The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics...

News

FDA invites comment on guidance on meetings with OTC sponsors

Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,”...

News

FDA invites comment on guidance on meetings with OTC sponsors

Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,”...

News

PREVENT Pandemics Act to build pandemic capabilities and implications for medical product developers

Earlier this week, the U.S. Senate HELP Committee released a discussion draft of the “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act”...

News

President Biden issues sweeping Executive Order to promote competition

On 9 July 2021 President Biden signed a far-reaching executive order intended to promote competition in the American economy. The order targets perceived corporate consolidation and...

News

Biden Administration Releases First 100-Day Review, Spurring Immediate Actions for US Supply Chains

Pursuant to Executive Order 14017, issued by President Biden on 24 February 2021, a federal government task force examined the vulnerabilities in America’s supply chains for...

News

In sharp rebuke to Trump Administration, HHS notice ending Unapproved Drugs Initiative is withdrawn

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug Administration’s (FDA) M...

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