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 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
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
Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more
Nearly 30 years ago, the first law authorizing the Food and Drug Administration (FDA) to collect fees from drug manufacturers to expedite the review of new prescription drug applications was enacted. Since then, additional...more
Food/Dietary Supplements - FDA Acting Commissioner Remarks on Smarter Public Food Safety – Dr. Sharpless stated, “I have been [a] strong proponent of leveraging new and emerging technologies and of developing novel analytical...more
Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more
Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
Lately, we have received a number of client inquiries about prescription user fee waivers. The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes FDA to collect fees from companies that produce certain human...more
The FDA has announced the rates for biosimilar user fees for the 2017 Fiscal Year... The biosimilar user fees for a given fiscal year are calculated as a percentage of the fee rate established under the Prescription Drug...more