The US Food and Drug Administration (FDA) recently published two new draft guidances to implement provisions of the Food and Drug Omnibus Reform Act (FDORA) aimed at refining the accelerated approval pathway. These guidances seek to address regulatory challenges and enhance oversight of drug products granted accelerated approval. Additionally, a recent report from the Office
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Navigating Key Challenges in M&A Deals in the Rare Disease Sector
By Morgan Lewis
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan , focusing on issues impacting the rare disease community.
Patient Assistance Programs – The Dos and Don’ts from HHS OIG
By Morgan Lewis
In honor of Rare Disease Day on February 28, 2025, Morgan Lewis is publishing a series of posts on As Prescribed and Health Law Scan throughout the month of February on issues impacting the rare disease community.
FCA Enforcement Risk Remains for Rare Disease Stakeholders
By Morgan Lewis
As we discussed in our blog post last week, 2024 saw the Department of Health and Human Services Office of Inspector General (HHS OIG) provide more concrete regulatory guidance for programs sponsored by pharmaceutical manufacturers that provide financial assistance and free genetic testing and counseling services to patients suffering from rare diseases. While the favorable…
FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025
By Morgan Lewis
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan , focusing on issues impacting the rare disease community.
Key Takeaways from the 2025 J.P. Morgan Healthcare Conference
By Morgan Lewis
Several members of our firm’s life sciences team were on the ground at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco from January 13 to 16, 2025. It was an exciting and sunny four days, during which key players from across the life sciences industry gathered to engage in deal discussions and consider…
Clinicaltrials.gov: Recent Action May Signal Increased Attention from FDA on Trial Data Reporting Compliance
By Morgan Lewis
The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice reflects FDA’s increasing attention toward noncompliance with the agency’s requirements for submission of clinical trials information and may signal an increase in enforcement that…
IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025
By Morgan Lewis
The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A). As the sector navigates a dynamic landscape of scientific advancements, economic pressures, and regulatory changes, stakeholders are increasingly leveraging strategic transactions to gain…
Prep, Pitch, and Connect at the JP Morgan Healthcare Conference
By Morgan Lewis
As the healthcare and life sciences industry gears up for the highly anticipated JP Morgan Healthcare Conference later this month, stakeholders across the sector are focusing on key trends and strategies to make the most of this unparalleled networking and deal-making event. To help attendees make the most of the 2025 conference and related events,…