Hogan Lovells Podcasts
Podcast: Talking the cure
25 March 2022
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...
Publications
News
FDA issues final guidance for importing drugs prior to anticipated approval
08 March 2022
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
23 February 2022
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
12 February 2022
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,”...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
12 February 2022
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs,”...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
28 January 2022
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
12 July 2021
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
11 June 2021
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In sharp rebuke to Trump Administration, HHS notice ending Unapproved Drugs Initiative is withdrawn
01 June 2021
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...
