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Focus on Regulation

Tag Archives: citizen petition

FTC backs FDA guidance intended to curtail citizen petition “shenanigans”

On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. This is the latest public step by the agency to highlight its continued close scrutiny of potential abuses of the citizen petition process to block or

New Rule Amends FDA’s Citizen Petition Regulations to Implement Section 505(q) of the Food, Drug, and Cosmetic Act

The U.S. Food and Drug Administration (FDA) has issued a final rule implementing section 505(q) of the Federal Food, Drug, and Cosmetic Act (FDCA).  Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets, 81 FR 78500 (Nov. 8, 2016). Congress enacted 505(q) with the purpose of ensuring that

FDA Notifies Applicants of Intent to Require Sweeping Changes to Labeling for IR Opioid Analgesics and Entire Class of Prescription Opioids

FDA has announced its intent to require new class-wide labeling requirements for immediate-release (IR) opioid pain medications including new black and other safety warnings.  The enhanced warnings are intended “to inform prescribers and patients of additional risks related to opioid use.”  FDA, News Release (March 22, 2016) (hereinafter, “News Release”).  FDA further announced its intent

Federal Circuit Revives Certain Sham Petitioning Antitrust Counterclaims in Tyco-Mutual ANDA Litigation

In a split decision, the U.S. Court of Appeals for the Federal Circuit affirmed summary judgment on two antitrust counterclaims brought by Mutual Pharmaceutical Co. (“Mutual”) against Tyco Healthcare Group (“Tyco”), while vacating summary judgment on two others.  Although the ruling is just the latest in a long line of cases analyzing sham petitioning issues