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…here, would entitle brand pharmaceutical companies, as a matter of law, to manipulate the FDA regulatory process and undermine state and federal laws that encourage generic competition,” writes the FTC….
…drugs for the relief of cough, cold, or allergy. The action will likely affect hundreds of marketed unapproved drug products evaluated under the Drug Efficacy Study Implementation (“DESI”) program – …
…includes provisions addressing drug importation and counterfeiting, device accessory classification, over-the-counter hearing aids, risk-based device inspections, generic drug product-specific bioequivalence guidance, real-world evidence, and pediatric drug development, among other things….
By Riëtte van Laack – On March 13, 2014, U.S. Senator Jack Reed (D-RI) and U.S. Representative Ed Whitfield (R-KY) introduced the “Sunscreen Innovation Act” (S. 2141 and H.R. 4250,…
…that statute [by CMS], contrary to dozens of other federal agency and State statutes and regulations, contrary to long-standing industry practices, and contrary to common sense. Furthermore, the associations question…
…of risk information in various promotional pieces. On May 26, 2009, FDA issued a draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion. The Draft…
Title XI (§ 1112) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) requires pharmaceutical applicants (both brand and generic) to file with the Federal Trade Commission…
…code. The annual deadline for this report is not specified. Second, by July 1 every year, a covered drug or device company must also report the “value, nature, purpose and…
By James R. Phelps – On November 7, 2008, the First Appellate District in the Court of Appeal of the State of California, which sits in San Francisco, issued a…
…the proposed indication, dosage form, route and frequency of administration, strength, unit of measure, dosage units, recommended dose, typical quantity or volume, product packaging, storage conditions, and patient and prescriber…
…the drug for more than 12 weeks at a time, that the physician relied on that information, and as a result, the plaintiff suffered injury. The trial court, reversed by…
…fulfill that commitment to the American people . . . . Rather than working on a piecemeal basis, company or company or drug by drug, what we have wanted to…
Two Hyman, Phelps & McNamara, P.C. (HPM) Directors, Karla Palmer and Dara Levy, will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance…
…each prescription drug product, both new prescriptions and refills, approved under [FDC Act § 505] and dispensed to consumers by pharmacies and authorized dispensers in an outpatient setting. FDA is…
…in the production, preparation, propagation, compounding, processing, packaging, repacking, distributing, or labeling of prescribed products,” although it excludes a wholesale distributor of biological products or a licensed pharmacist. The law’s…