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…searching of product names or claim language. A key word “Quick Search” can also be conducted of the entire database. For example, a Quick Search using the term, “probiotic” yields…
…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…
…scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media.” 21 C.F.R. §312.7. This is not the first time FDA has admonished CytoDyn’s communications about…
…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….
…definition of certain terms that are not defined by regulation (e.g., “equilibrium pH”). Comments on the guidance are due December 27. Of late, FDA has shown increased interest in exercising…
…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.,…
…Controlled Substances Act and the Drug Enforcement Administration. The webinar is scheduled to take place on Tuesday, April 27, 2021, from 2:00 p.m. – 4:00 p.m. (ET). AGENDA: State of…
…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…
…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….
…Controlled Substances Act and the Drug Enforcement Administration. The webinar is scheduled to take place on Tuesday, April 27, 2021, from 2:00 p.m. – 4:00 p.m. (ET). AGENDA: State of…
…the webinar and they will be posed anonymously during the webinar. Or send them to during the webinar. Moderator: Juan Carlos Serna, Co-Founder & CEO, Right Submission Presenter: Jeffrey N….
…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…
…which has shown anti-viral and anti-inflammatory properties to help reduce lung inflammation in COVID-19 patients. Zoom information will be given upon registration. For more information contact, bbogage@marylandisrael.org. To register: https://midcisraelcovid19.eventbrite.com…
…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…
The accolades keep rolling on in . . . . USPharmD has named the FDA Law Blog one of the “Top 50 Medical Ethics Blogs.” According to them, we will…