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 colleagues in other related life science disciplines.
Industry Insights
Don’t Pay the Ferryman, Don’t Even Fix a Price: FDA Issues Draft Revision to Its Questions and Answers Guidance About Charging for Investigational Drugs Under an IND
By Alan G. Minsk and Kadeja A. Watts
In 1982, Chris de Burgh (of “Lady in Red” fame) sang, “Don’t pay the ferryman, don’t even fix a price until he gets you to the other side,” where the narrator warns the passenger not to pay the ferryman (because a storm approaches). Forty years later, in August 2022, the Food and Drug Administration issued its first revision to its 2016 guidance for industry titled, “Charging for Investigational Drugs Under an IND Questions and Answers.” The agency intends that the guidance may help industry understand how it intends to implement its regulation on charging for investigational drugs under an investigational new drug application (“IND”) for the purpose of either clinical trials or expanded access for treatment use. FDA, similar to Chris de Burgh, wants to protect the patient (or passenger).
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FDA Tries to Satiate Its Orange Crush and Issues a Q&A on the Orange Book
By Alan G. Minsk and Kadeja A. Watts
In a colorful nod to one of Georgia’s most famous and respected musical bands, R.E.M., and its 1988 hit, “Orange Crush” (from the album Green — coincidence?), in July 2022, the Food and Drug Administration issued a guidance for industry titled, “Orange Book Questions and Answers.” The agency intends that the guidance should help the drug industry more efficiently utilize the Approved Drug Products With Therapeutic Equivalence Evaluations publication (commonly referred to as “the Orange Book”).
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AGG's Due Diligence of FDA Regulations Aids ARS Pharmaceuticals in Improving Treatment for Severe Allergic Reactions
By Alan G. Minsk, Bob Durkin, and Laura S. Dona
A Type I severe allergic reaction can be a potentially life-threatening event requiring immediate treatment with epinephrine, the only FDA-approved medication for these reactions. Although epinephrine autoinjectors are highly effective, certain limitations can delay treatment in an emergency, including fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. To address these issues, ARS Pharmaceuticals, Inc. (“ARS”), headquartered in San Diego, California, is developing neffy™, a needle-free intranasal epinephrine spray for use as a rescue medication for people with severe allergic reactions. neffy™ has a unique absorption technology that is easy to use and is designed to rapidly administer injection-like absorption of epinephrine in a nasal spray device for patients at risk of severe allergic reactions to food, medications, and insect bites that could lead to life-threatening anaphylaxis.
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