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News

Inflation Reduction Act’s Drug Price Negotiation Program explained

In the first of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe discussed the Drug Price...

News

Spotlight on Greater China: recent developments governing health related data and HGR

As part of a new Asia-Pacific (APAC) Life Sciences and Health Care webinar program designed both for companies with commercial interests in APAC and for companies based in the region, Hogan ...

Analysis

Mexico Ministry of Health issues changes to food advertising law and front-of-pack-packing
Registered Content

Two weeks ago, the Mexican Ministry of Health passed an amendment to two main regulations governing labelling and advertising of food products and beverages. The amendment intends to (i)...

News

(Patient) safety first: take steps now to promote good governance by your board

Earlier this year, the Delaware Chancery Court approved a breathtaking $237.5 million settlement of derivative claims brought against Boeing’s board for breach of fiduciary duties...

Hogan Lovells Podcasts

"Thanks... Good Talk" Shortcast

Ivan Zapien and Mark Irion focus their shortcast on the issues, people, and culture that help shape Washington, D.C.

News

FDA offers new guidance on charging for investigational drugs

On Monday, the U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Charging for Investigational Drugs Under an IND: Questions and Answers,” which...

News

OIG audit finds lack of compliance with ClinicalTrials.gov reporting requirements from NIH studies

A newly released audit by the Office of Inspector General (OIG) found that for clinical trials funded by the National Institutes of Health (NIH) for which responsible parties were required...

News

Six strategies for clinical trial & marketing application success as FDA requires HCT/P BLAs

Now that FDA’s grace period for regenerative medicines has ended, many manufacturers of human cell, tissue, or cellular- or tissue-based products (HCT/Ps) will be required to file a...

News

FDA plans to expand remote evaluations, record reviews post-pandemic

The U.S. Food and Drug Administration (FDA) recently issued draft guidance on how it will continue to conduct remote regulatory assessments (RRAs) after the COVID-19 public health emergency ...

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