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FDA Announces Intent to Take Enforcement Action With Respect to Certain Marketed Unapproved Oxycodone Drug Products; Denies Lannett “Grandfather” Drug Petition
…of opium and a Schedule II controlled substance, “pose particular safety concerns because of their potential for addiction.” FDA illustrates this point by citing several examples of marketed unapproved Oxycodone…
Compounders Can Relax, But Not Too Much
…gesture of flexibility, FDA also asks outsourcing facilities and the public to comment on two alternative measures that could take some of the load off outsourcing facilities. FDA asks for…
A Fumble Return, Not a Punt Return, in the First FDA Resolution of a 180-Day Exclusivity Punt Case
…generic drug exclusivity. It will do so only if another paragraph IV applicant becomes eligible for full approval (a) within 180 days after Barr begins commercial marketing of Dutasteride Capsules,…
FDA’s New Interpretation of GDUFA: It Depends Upon What the Meaning of the Word “New” Is
…small or mid-size) generic drug manufacturer with several affiliates, which, in turn, have multiple FDF or API manufacturing facilities, you have to be particularly careful that all facility fees that…
California Supreme Court to Review Whether the Organic Food Production Act of 1990 Preempts State Consumer Lawsuits Regarding Organic Mislabeling
…products under its ‘100% Organic’ label.” Allegedly, Herb Thyme mixed organic and conventional herbs and labeled the final product as 100% “Fresh Organic” products. Ms. Quesada brought claims for (1)…
The Ascension of FDA’s September 19, 2011 Marketed Unapproved Drugs Compliance Policy Guide
…approval and over-the-counter drug monograph systems. The September 2011 Unapproved Drugs CPG also drew a new line in the sand for enforcement discretion purposes. In it FDA states: The enforcement…
Game On! The HP&M Crossword Puzzle
…1995 37. Popular OTC IVDs 38. Confirmed Agency official? 42. Attorney William who signed the Articles of Confederation in 1778 43. Like some dealings or figures 44. Also 45. Demand…
Did FDA Shed Light on the Meaning of “Market Withdrawal” in the Updated RPM? Unfortunately, No.
…withdrawal in its regulations. 21 C.F.R. § 7.3(j) defines “market withdrawal” as: a firm’s removal or correction of a distributed product which involves a minor violation that would not be…
At EFLA’s Third EU-US Food Law Conference, An Invigorating Discussion of International Recalls
…public notices – critical events in the conduct of a recall. Much discussion was devoted to the EU’s rapid alert system, to which participating countries are required to submit notice…
Act II, Scene II: A Rose By Any Other Name Would Smell as Sweet? “No!” Says GPhA in Citizen Petition to FDA on Biosimilar Naming
…like the Alliance for Safe Biologic Medicines (“ASBM”). As we previously reported, ASBM has urged FDA to adopt unique non-proprietary names for all biological products licensed under the PHS Act,…
Recommendations of FDASIA Health IT Workgroup Accepted
…its risk-based approach. Of particular interest is the recommendation that health IT should generally not be subject to FDA premarket requirements, with a few exceptions: medical device accessories, high-risk clinical…
Might You Be An “Importer” for Purposes of FSMA’s FSVP Requirement? Now You Know.
…light of the previously published Preventive Controls and Produce Safety rules. Among the questions to consider is whether vertical integration of supply chains might offer potential advantages under the coming…
Traditional Meat Industry’s Beef With Alternative Protein Continues with the FAIR on Labels Act
…Senate. Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims….
All Device Manufacturers Must Report!
…hospital or clinic staffing of devices with alarms. All the manufacturer is responsible for is assuring its devices work as intended, including that the alarm operates when it is supposed…
FTC Annual Report Highlights Commission Focus on Health-Related Advertising
…ever on health-related advertising – especially where advertising allegedly promotes products for weight loss or disease treatment or prevention. The annual report includes a summary of significant advertising matters litigated…