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…Application for accreditation of this program for Continuing Legal Education (CLE) in California, Massachusetts, New Jersey, and New York is currently pending. For questions, please contact Reiko Tate (reiko.tate@dechert.com). …
…scheduled for Friday, October 8, 12:00 p.m. – 1:30 p.m. For those last minute stragglers, there’s still time to register at the event website. (Registration will close 3 hours before…
…14th approval of Watson Laboratories, Inc.’s ANDA No. 78-278 for a generic version of the herpes drug FAMVIR (famciclovir) Tablets, FDA, on September 24th, updated the Agency’s drug approval database (Drugs@FDA)…
…in 1982 Federal Register notices. According to FDA, since 1969, when FDA first implemented an adverse event reporting system, and as of 2005, the Agency “has received more than 400…
…provide adequate information regarding those data to allow critique of them. Banner Health v. Price, 867 F.3d 1323, 1335 (D.C. Cir. 2017); United States Lines, Inc. v. Federal Maritime Com.,…
…authority of section 404 of the Federal Food, Drug, and Cosmetic Act, after a New York banker was killed by botulism in a can of Bon Vivant vichyssoise – an…
…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…
…NDA that support the inclusion of each statement in the labeling. 21 CFR 314.50. Needless to say, teams of professionals, including clinicians, statisticians, pharmacists, clinical pharmacologists, and commercialization and reimbursement…
…quality metrics, as discussed in prior blogposts (here, here, and here). Moreover, FDA encourages industry to aim for continuous improvement in manufacturing, laboratory, and quality systems. So, back to corn…
…pending. Application for accreditation of this program for Continuing Legal Education (CLE) in California, Massachusetts, New Jersey, and New York is currently pending. For questions, please contact Reiko Tate (reiko.tate@dechert.com)….
…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…
…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…
…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….