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…OTC hearing aids in their stores or on their websites, and some are available at audiology clinics. And the number of companies selling OTC hearing aids is impressive: as of…
…an OTC monograph, which basically serves as an instruction manual for making and labeling certain OTC drugs. Relevant to our conversation, OTC monographs establish conditions—such as active ingredients and indications…
…points: First, a generic drug manufacturer is not absolved of liability because the FDA has approved its generic product. The Hatch-Waxman Act allows generic drug makers to expeditiously get their…
…PLAN B One-Step) available Over-the-Counter (“OTC”) and without point-of-sale or age restrictions (see our previous post here). (Judge Korman recently clarified that the 30-day deadline for compliance with his order…
…in the repository. For each OTC monograph title (e.g., nighttime sleep aid drug products), the repository provides an OTC Monograph ID (e.g., M002) and an Order ID (e.g., OTC000001) and…
…add Section 505H, titled “Competitive Generic Therapies.” As explained by Rep. Schrader in his opening remarks: We know that when generic drugs compete in the market, drug prices come down…
…yes, generic competition is anemic for some products, typically more complex products, there is a glut of competition for others. The Drug Competition Action Plan attempts to introduce more competition…
…to avoid some generic drug labeling carve-outs. Companies may seek to clarify Orange Book method-of-use patent listings – and may petition FDA regarding the same – in efforts to prevent generic…
…the skinny label may effectively be dead for any risk-averse generic sponsor (given the potential for treble damages for a blockbuster product with no generic competition). The generic industry anxiously…
…Kathleen “Cook” Uhl, M.D. and OGD Regulatory Counsel Keith Flanagan laid out in presentations the Office’s accomplishments and introduced the GDUFA Steering Committee – a committee composed of senior FDA…
…Budget states: [T]he Budget proposes to give the Food and Drug Administration (FDA) greater ability to bring generics to market faster by incentivizing more competition among generic manufacturers. This would…
…court goes on to comment in a footnote, however, about the applicability of Levine to generic drug manufacturers: Levine did not address generic drugs and if or how its analysis…
…Though there has been a large number of OTC IVD clearances and decades of experience reviewing OTC IVDs, the bulk of OTC IVD clearances fall in just a few categories,…
…brand-name companies to compensate generic competitors for delaying entry.” The final report contains four main findings: Competition from authorized generics during the 180-day marketing exclusivity period has led to lower…
…New Definitions DEA’s proposed rule establishes three new definitions: (1) “orders received under suspicious circumstances (ORUSC),” (2) “order,” and (3) “due diligence.” DEA’s existing regulations only define a “suspicious order,”…