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Warning Letters Life Sciences Prescription Drugs

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - April 2024

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This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more

Arnall Golden Gregory LLP

What Would Al Stewart Think About OPDP’s Latest Untitled Letter: A Sign of More Enforcement?

In his 1973 song, “Nostradamus,” singer-songwriter Al Stewart sang, “I am the eyes of Nostradamus, all your ways are known to me.” So, we started thinking, what would Mr. Stewart think of FDA’s Office of Prescription Drug...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - August 2023

Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup 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

Arnall Golden Gregory LLP

It's the Little Things: FDA Issues a Warning Letter for Improper Drug Listing

In a nod to Alice Cooper’s 2000 song, “It’s the Little Things” (or, for literary fans, Robert Frost’s quote, “It’s the little details that are vital; little things make big things bigger”), the Food and Drug Administration’s...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

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