Laura Carpenter, the author of this column is an attorney and third-generation pharmacist. She is the founder of Carpenter Law Firm PC and can be reached at carpenter@lcarpenterlawfirm.com.
When Congress enacted the Federal Food, Drug, and Cosmetic Act, or FDCA, in 1938, it required New Drug Applications or NDAs for all new drugs. One unresolved legal question has been whether the NDA requirements apply to compounded drugs. Read More
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