The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more
On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more
The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more
The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more
The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more
With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more
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.
The value of merger and...more
2/21/2025
/ Acquisitions ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Investors ,
Life Sciences ,
Mergers ,
OIG ,
Pharmaceutical Industry ,
Private Equity ,
Regulatory Requirements ,
Risk Management
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...more
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be no exception to this rule, and with its arrival we examine FDA’s activities...more
Heading into the new year, a Trump-Vance administration will control the White House and the Republicans will hold a narrow majority in both the House and Senate. This control trifecta is likely to impact both legislative and...more
12/5/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Beneficiaries ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Section 340B ,
Trump Administration
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question how this political shift...more
The development of psychedelic drugs for medicinal uses has substantially expanded since 2020, as evidenced by an exponential growth in Drug Enforcement Administration (DEA) production quotas for both psilocybin and psilocin....more
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees...more
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies. While the draft...more
It is hard to believe that we are already in February and it has been a month since the 42nd Annual JP Morgan Healthcare Conference in San Francisco wrapped. It was a packed four days in which the major players in the life...more
The ball has dropped on the healthcare and life sciences industry’s unique New Year tradition, the J.P. Morgan Healthcare Conference, so all eyes turn to 2024. To help define a path forward, Morgan Lewis FDA and healthcare...more
The US Food and Drug Administration (FDA) was busy in 2023 with significant, and even bullish, developments occurring across several areas, from drug and biologic development and manufacturing to labeling, advertising, and...more
In a continuing effort to improve the quality system effectiveness of human drug manufacturing sites, FDA revised MAPP 5014.1, Understanding CDER’s Risk-Based Site Selection Model (Site Selection MAPP or the Policy)....more
As drug shortages are once again front-page crises news, demanding drastic action by FDA—currently with a particular focus on sterile, injectable platinum-based chemotherapy drugs—a refresher on the scope of FDA’s tools to...more
While the US Court of Appeals for the Fifth Circuit has temporarily stayed the Texas district court’s ruling invalidating the US Food and Drug Administration’s (FDA’s) approval of mifepristone, the decision will still...more
While many provisions of the FY 2023 Consolidated Appropriations Act (Omnibus) have received much attention, one has flown under the radar. In its explanatory statement on the Omnibus, the US Congress indicated that it is...more
The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations...more
While the Biden administration and US Congress continue to debate ways to address perceived prescription drug pricing concerns, the Food and Drug Administration (FDA) is taking action. Under its Drug Competition Action Plan...more
The US Senate voted on February 15 to confirm Dr. Robert M. Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. Janet...more