Weinberger v. Bentex Pharmaceuticals, Inc.

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

• noting that in 1973 there were between 100,000 and 500,000 OTC drugs on the market, few of which were previously approved by the FDA
• interpreting § 355(h) narrowly and endorsing district court jurisdiction to hear appeals from orders affecting new drug status
• explaining the FDA has jurisdiction to decide the status or class of a medical product
• fearing suits testing the status of each newly developed “me-too” drug
• fearing suits testing the status of each newly developed \me-too\ drug
• “Threshold questions within the peculiar expertise of an administrative agency are appropriately routed to the agency, while the court stays its hand.”

Source: CourtListener parenthetical corpus (CC0).