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…on behalf of a prospective generic drug applicant. The Letter of Authorization that needed to be submitted was on company letterhead identifying “COMPANY NAME, INC.”, and the signature block identified…
…15 business days. Companies also must report all nonserious adverse events (broadly defined as health-related events that are adverse) in an annual report (this report may not include complaints about…
…such as roadside stands, farmers’ markets, Community Supported Agriculture (CSA) programs, and other direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online…
…consumers to comprehend and provides companies with a path forward to disseminating consumer-directed print labeling with an abbreviated statement of risk (referred to as the “consumer brief summary”) as opposed…
…electrical safety, electromagnetic compatibility, software, cybersecurity, human factors, and performance (which includes bench, animal, and clinical tests). Given this, it is common for firms to contract with independent labs (“third-party…
…Committee meeting was preceded by FDA’s release of a briefing document. The briefing document states that the analytical data show that both clinical and commercial lots of the Novartis product…
…13-1979 (RGA) (D. Del. Mar. 10, 2014) (here). Nevertheless, as detailed in a previous post, the practice has continued and spread among companies. But some recent events in court, as…
…the FDC Act (and the PHS Act, in the case of the BPCA as amended by the Biologics Price Competition and Innovation Act of 2009). According to Rep. Bilirakis, “The…
…these elements were met, argues the company: Cuvposa met the first hurdle for receiving pediatric exclusivity under § 505A(h) because the sponsor was required to complete pediatric studies for NDA…
…no longer subject to regulation by DEA. Costs/Benefits. DEA recognizes that collection and disposal of controlled substances is voluntary and costly. DEA notes that costs to collectors may be offset…
…and booking substantial sales revenue.” That almost sounds to us like commercial marketing. And under the statute (FDC Act § 505(j)(5)(b)(iv)(I)), commercial marketing triggering 180-day exclusivity includes “commercial marketing of…
…a letter to the Office of Management and Budget questioning FDA’s legal authority and cost-benefit analysis in issuing the proposed rule. That letter follows a hearing and several other letters,…
…in the just-issued OIG Supplemental Special Advisory Bulletin on Independent Charity Patient Assistance Programs (PAPs), we wonder whether the charities and pharmaceutical companies affected by them will find comfort in…
…Preliminary Regulatory Impact Analysis concerning some of the cost issues raised by the lawmakers, and also clarifies the proposal. For example, FDA comments that “[d]uring its review of a generic…
…best communicate those suggestions to the generic drug industry. Specifically, FDA is seeking comment “about any difficulties sponsors are having developing and preparing their ANDA submissions that FDA could help…