We previously reported on FDA’s plans to take enforcement action with respect to firms manufacturing and distributing unapproved drugs containing hydrocodone. According to the October 1, 2007 FDA Federal Register notice: Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than …
Last week, the United States Court of Appeals for the Seventh Circuit concluded that the Federal Trade Commission Act (“FTC Act”) does not require placebo-controlled, double-blind testing for consumer products. The ruling, issued in Federal Trade Commission v. QT Inc., upheld a decision by the …
Title VIII of the recently-enacted FDA Amendments Act (“FDAAA”) requires the responsible party of an applicable clinical trial (for both drugs and devices) to certify that the new requirements of Public Health Service Act (“PHS Act”) § 402(j) have been met. Under PHS Act § …
On December 21, 2007, the United States Attorney’s Office for the District of Massachusetts announced that pursuant to a plea agreement reached on October 30, 2007, under Federal Rule of Criminal Procedure 11(c)(1)(C), under which the parties can agree to the particular sentence imposed (subject …
On November 27, 2007, the Drug Enforcement Administration (“DEA”) issued a proposed rule to implement a new format for DEA Official Order Forms (so-called “DEA-222s”). DEA requires registrants to acquire Schedule I or II controlled substances using triplicate, carbon-paper DEA-222s. DEA observes that processing transactions …
