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…inflammatory complications associated with COVID-19. Vered Kaplan, CEO of Orgenesis, a global biotech company, which is unlocking the potential of cell and gene therapy including anti-viral technologies relevant for COVID-19…
…on drugs with potential safety risks. FDA’s action comes on the heels of an article on CNN.com and an editorial in the Wall Street Journal critical of the Agency’s handling…
The last time we blogged on news from a recent pharmaconference.com industry conference about current Good Manufacturing Practice (“GMP by the Sea,” agenda linked here), we provided some cute references…
At the cGMP conference sponsored by pharmaconference.com earlier this month, FDA’s compliance wing encouraged pharmaceutical companies to ensure that they demonstrate “quality maturity,” and offered specifics about what FDA wants…
…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…
…practice (“CGMP”) requirements in 21 CFR part 114 and the “Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit” in 21 CFR 108.25. Those regulations impose…
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…
…entities. Comments on both Notices are due by November 19. HRSA says it will consider the comments in formulating its proposed regulations. There will be another opportunity to comment on…
…Drug Bar will address a broad range of topics, including: FTC address on pharmaceutical antitrust In depth analysis of recent court cases and their implications on brand and generic companies…
…the decision below did serious damage to a federal statute of the highest importance. In concrete terms, the decision below will confer massive anti-competitive advantages on drug companies (both generic…
…by Dechert LLP and Hyman, Phelps & McNamara P.C., will discuss recent pharmaceutical supply chain developments and what steps companies need to take to prevent and remediate compliance issues in the…
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials AND a critical competency for legal and business professionals in the biopharmaceutical arena AT THE American Conference Institute’s (ACI’s) 3rd Annual…
…of food and drug law and regulation to assist with a growing practice. Strong verbal and writing skills are required. Compensation is competitive and commensurate with experience. HP&M is an…
…of food and drug law and regulation to assist with a growing practice. Strong verbal and writing skills are required. Compensation is competitive and commensurate with experience. HP&M is an…