Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
The U.S. Food and Drug Administration (FDA) recently published its criteria for reporting on the use of real-world evidence (RWE) in drug and biologic submissions, as part of its commitments under the Prescription Drug User...more
Cloud services have revolutionized the way businesses and governments operate, offering scalability, flexibility, cost-efficiency and security. This is especially the case in the life sciences industry, where the cloud has...more
The Agency’s recent draft guidance document on formal meetings with PDUFA product sponsors and applicants could increase opportunities for interactions between FDA and industry stakeholders. On September 22, 2023, the US...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On September 20, Merck announced that the U.S. Food and Drug Administration (FDA) granted priority review status to Merck’s supplemental Biologics License Application (sBLA) seeking approval for its anti-PD-1 therapy KEYTRUDA...more
On March 23, the U.S. Food and Drug Administration (FDA) published a framework to guide regulatory decision-making on the use of digital health technologies (DHT) in clinical drug trials. DHTs include a wide array of...more
On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center...more
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
The Food and Drug Administration’s (FDA) user fee programs, which pay the salaries of agency staff who review drug and medical device applications, are set to expire on October 1, 2022. These include the Prescription Drug...more
Update on UFA Reauthorization Legislation - As outlined in Akin Gump’s previous analysis, the current five-year authorization of the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and...more
With just a few short weeks left until August recess, there is no shortage of items on the congressional to-do list. The latest round of Supreme Court decisions has inspired new action within Congress to pass legislation...more
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA will analyze whether to rescind a breakthrough therapy...more
On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more
Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and...more
On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
We are just one quarter into 2022 and the Food and Drug Administration (FDA) already has experienced a number of significant changes and developments. A new commissioner has been confirmed (Robert Califf, M.D., who previously...more
While Congress has a two-week recess in April, there are many priority items on the agenda this month. Less than two weeks after signing the Fiscal Year (FY) 2022 spending package, President Biden released his budget for FY...more
With the second session of the 117th Congress underway, stakeholders are poised for another busy legislative session set against the dynamic backdrop of an ongoing global pandemic and midterm election year. Numerous...more
As the 117th Congress moves into its second legislative session, there is no shortage of health care policy issues dotting the landscape. The COVID-19 pandemic, legislative gridlock and a 2021 that was largely locked down by...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Many of us remember the Seinfeld episode where the owner of a soup restaurant refuses to fulfill an order if the consumer talks back or otherwise upsets him, angrily stating, “No soup for you.” Recently, the Food and Drug...more
Nearly five months after releasing their initial 21st Century Cures 2.0 draft, Congressman Fred Upton (R-MI) and Congresswoman Diana DeGette (D-CO) introduced the long-anticipated bill on November 15. The bill includes...more
In late September, the Food and Drug Administration (FDA) released a draft guidance on benefit-risk assessments for drugs and biological products. The draft guidance includes considerations the agency uses when weighing the...more
On August 23, 2021, the Food and Drug Administration released the PDUFA VII commitment letter, which contains the agency’s performance goals for the five-year window (Fiscal Year 2023 to 2027) covered by the next iteration of...more