Letter to FDA Regarding Proposed Change to Generic Drug Labeling Policy
Excerpt: We are writing to express grave concerns regarding a regulation … that would change longstanding policy regarding the 1984 Hatch-Waxman Act. The proposed regulation would allow generic manufacturers to alter an abbreviated new drug application (ANDA) label without the FDA’s prior approval.
To read the letter, click here.
To read a related press release, click here.
To read a response from FDA, click here.