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…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…
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…
…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…
…data for product components developed in a complex global supply chain. This requirement will be expanded exponentially once California’s Department of the Office of Health Hazard Assessment (“OEHHA”) issues its…
…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…
…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…
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…
…culture is collaborative, the work environment is flexible, and the subject matter is intellectually stimulating. If you want to join our team, please send your resume to Anne Walsh, awalsh@hpm.com….
…Act, Proposed SOM Rule, the “ORUSC,” and Distribution Trends (3:20 – 4:00 p.m.) Larry K. Houck and Kenneth Weinstein To RSVP for this program, please email Amy Vasvary at avasvary@hpm.com…
…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….
…Act, Proposed SOM Rule, the “ORUSC,” and Distribution Trends (3:20 – 4:00 p.m.) Larry K. Houck and Kenneth Weinstein To RSVP for this program, please email Amy Vasvary at avasvary@hpm.com…
…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.,…
…on news platforms, and FDA’s interest in sponsored news segments, companies should be treating these opportunities the same way they would treat more traditional promotional communications and ensure truthful communications….
…big firm experience, including litigation experience, and a federal judicial clerkship. E-discovery expertise is a bonus. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please…