United States: Food, Drugs, Healthcare, Life Sciences

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
The Race For Clinical Trials: Can The FDA’s New Pilot Program Stop The U.S. From Falling Behind?
The United States has lost approximately 10% of its global share of Phase 1 clinical trials since 2015, with China now accounting for 39% of all global trials by 2024. The FDA's new Expedited IND Pilot Program introduces Qualified Research Institutions and rolling submissions to help sponsors reach first-in-human dosing faster domestically. For life sciences companies whose financing depends on rapid trial initiation, this program could fundamentally reshape development strategy and restore U.S. competitive
United States Healthcare
FH
Foley Hoag LLP
Article
PBM Policy And Legislative Update — Fall 2026
Mintz's Managed Care, PBMs & Pharmacies practice examines critical federal and state developments impacting pharmacy benefit managers and the prescription drug supply chain from mid-February through June 2026. This comprehensive quarterly update analyzes legislative activity, regulatory changes, enforcement actions, and emerging market trends affecting PBMs, health plans, pharmacies, manufacturers, and industry stakeholders navigating an evolving regulatory landscape.
United States Healthcare
M
Mintz
Article
When FDA Oversees Trials Overseas: Foreign Clinical Trial Considerations
The FDA's acceptance of foreign clinical trial data hinges on strict compliance with good clinical practice standards, population representativeness, and data integrity requirements that sponsors must carefully navigate. As the agency intensifies scrutiny of non-U.S. trial sites and emphasizes demographic diversity in study populations, pharmaceutical companies face mounting challenges in ensuring their international research programs meet evolving regulatory expectations.
United States Healthcare
FH
Foley Hoag LLP
See more

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Food and Drugs Law

Article
The Race For Clinical Trials: Can The FDA’s New Pilot Program Stop The U.S. From Falling Behind?
The United States has lost approximately 10% of its global share of Phase 1 clinical trials since 2015, with China now accounting for 39% of all global trials by 2024. The FDA's new Expedited IND Pilot Program introduces Qualified Research Institutions and rolling submissions to help sponsors reach first-in-human dosing faster domestically. For life sciences companies whose financing depends on rapid trial initiation, this program could fundamentally reshape development strategy and restore U.S. competitive
United States Healthcare
FH
Foley Hoag LLP
Article
PBM Policy And Legislative Update — Fall 2026
Mintz's Managed Care, PBMs & Pharmacies practice examines critical federal and state developments impacting pharmacy benefit managers and the prescription drug supply chain from mid-February through June 2026. This comprehensive quarterly update analyzes legislative activity, regulatory changes, enforcement actions, and emerging market trends affecting PBMs, health plans, pharmacies, manufacturers, and industry stakeholders navigating an evolving regulatory landscape.
United States Healthcare
M
Mintz
Article
When FDA Oversees Trials Overseas: Foreign Clinical Trial Considerations
The FDA's acceptance of foreign clinical trial data hinges on strict compliance with good clinical practice standards, population representativeness, and data integrity requirements that sponsors must carefully navigate. As the agency intensifies scrutiny of non-U.S. trial sites and emphasizes demographic diversity in study populations, pharmaceutical companies face mounting challenges in ensuring their international research programs meet evolving regulatory expectations.
United States Healthcare
FH
Foley Hoag LLP
See more

Life Sciences, Biotechnology & Nanotechnology

Article
The Race For Clinical Trials: Can The FDA’s New Pilot Program Stop The U.S. From Falling Behind?
The United States has lost approximately 10% of its global share of Phase 1 clinical trials since 2015, with China now accounting for 39% of all global trials by 2024. The FDA's new Expedited IND Pilot Program introduces Qualified Research Institutions and rolling submissions to help sponsors reach first-in-human dosing faster domestically. For life sciences companies whose financing depends on rapid trial initiation, this program could fundamentally reshape development strategy and restore U.S. competitive
United States Healthcare
FH
Foley Hoag LLP
Article
Intellectual Property Strategy In An Era Of Foreign Clinical Trials
Biotech companies conducting early-stage biologics trials outside the United States face complex intellectual property challenges that can significantly impact their ability to secure U.S. market exclusivity. Foreign clinical trial registrations, contractor disclosures, and misaligned regulatory timelines create prior-art risks and patent forfeiture scenarios that many companies fail to anticipate. This analysis examines how strategic patent filing coordination with foreign Phase I development can preserve
United States IP
FH
Foley Hoag LLP
See more

Healthcare

Article
The Race For Clinical Trials: Can The FDA’s New Pilot Program Stop The U.S. From Falling Behind?
The United States has lost approximately 10% of its global share of Phase 1 clinical trials since 2015, with China now accounting for 39% of all global trials by 2024. The FDA's new Expedited IND Pilot Program introduces Qualified Research Institutions and rolling submissions to help sponsors reach first-in-human dosing faster domestically. For life sciences companies whose financing depends on rapid trial initiation, this program could fundamentally reshape development strategy and restore U.S. competitive
United States Healthcare
FH
Foley Hoag LLP
Article
Intellectual Property Strategy In An Era Of Foreign Clinical Trials
Biotech companies conducting early-stage biologics trials outside the United States face complex intellectual property challenges that can significantly impact their ability to secure U.S. market exclusivity. Foreign clinical trial registrations, contractor disclosures, and misaligned regulatory timelines create prior-art risks and patent forfeiture scenarios that many companies fail to anticipate. This analysis examines how strategic patent filing coordination with foreign Phase I development can preserve
United States IP
FH
Foley Hoag LLP
Article
PBM Policy And Legislative Update — Fall 2026
Mintz's Managed Care, PBMs & Pharmacies practice examines critical federal and state developments impacting pharmacy benefit managers and the prescription drug supply chain from mid-February through June 2026. This comprehensive quarterly update analyzes legislative activity, regulatory changes, enforcement actions, and emerging market trends affecting PBMs, health plans, pharmacies, manufacturers, and industry stakeholders navigating an evolving regulatory landscape.
United States Healthcare
M
Mintz
See more

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