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…the CytoDyn video, describes itself as “enabl[ing] companies and investors to connect intelligently.” Proactive’s Terms and Conditions includes the following statement: In exchange for publishing services rendered by the Company…
Hyman, Phelps & McNamara, P.C. is the largest dedicated FDA law firm, and we need attorneys to help our clients bring pharmaceutical drugs and medical devices to market. Our ideal…
…whether supply chain disruptions are leading to specific bottlenecks, shortages, anti-competitive practices, or contributing to rising consumer prices.” The recent section 6(b) orders were sent to Walmart Inc., Amazon.com, Inc.,…
…review.” While valor suggests that an applicant should stand its ground and fight for its drug, many companies understandably choose to accept FDA’s imperfect edits. (As an aside, this is…
…Anne K. Walsh (awalsh@hpm.com). Candidates must be members of the DC Bar or eligible to waive in. Compensation is competitive and commensurate with experience. HPM is an equal opportunity employer….
A biotech company facing a complete response letter (CRL) action on its NDA/BLA has no greater goal than to quickly and fully understand the deficiencies that FDA has identified in…
Hyman, Phelps & McNamara, P.C. and Analysis Group are partnering to host a two-hour timely, informative and free program to discuss current important legal perspectives and analytical trends concerning the…
…78 102 12 192 United States 232 384 68 684 As for devices, the number of FDA inspections of medical device manufacturing facilities outside the United States increased by 243…
…mature quality systems also applies equally to medical device companies and to pharmaceutical companies. Preliminarily (a word I doubt my grandmother used very often), we should note that FDA’s advice…
…a detailed understanding of FDA and the regulatory process. Compensation is competitive and commensurate with experience. HPM is an equal opportunity employer. Please send your curriculum vitae, transcript, and a…
…regulation is preferred; strong research and writing skills are required. Compensation is competitive and commensurate with experience. HPM is an equal opportunity employer. Please send your curriculum vitae, transcript, and…
…consumer product is very broad but does exempt dangerous drugs or devices; dental restorative materials; foods; pesticides; and mercury- containing lights. (Mercury-containing devices are only exempted from these regulations until…
…event that pushed Bon Vivant into bankruptcy. The guidance discusses the differences between acid foods and acidified foods, the applicability of FDA’s requirements to fermented foods, the obligations of repackers…
…bioequivalence issues and that involve the first marketing of a generic, the Novartis lawsuit takes issue with patent certification/“section viii” labeling carve-out statement issues and involves a subsequent approval. (Back…
Transparency and data disclosure are this year’s hot issues for pharmaceutical companies. On the clinical trial front, Europe is leading the way, with initiatives from the European Medicines Agency and…