Alan G. Minsk

Partner
171 17th Street NW
Suite 2100
Atlanta, Georgia 30363
404.873.8690 phone
404.873.8691fax

Representative Experience

  • Assisted with the review of agreements for Puma Biotechnology for clinical trials of a new breast cancer medication to be conducted in Russia.
  • Advised a U.S. biotechnology company in connection with clinical trials of a new breast cancer medication to be conducted in Russia.
  • Assisted clients with preparation of regulatory opinion for IPO filings.
  • Serves on multiple client promotional review boards for pharmaceutical and medical device companies as the legal representative to ensure  regulatory compliance of FDA's labeling and promotional requirements.
  • Counseling an Alabama-based manufacturing company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.
  • Worked with the FDA’s Office of the Ombudsman to help facilitate meetings or discussions between a pharmaceutical company sponsor and the FDA on a stalled clinical development program and when communications broke down.
  • Counseling pharmaceutical companies on regulatory issues relating to 505(b)(2) new drug applications and orphan drug issues.
  • Counseling a pharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.
  • Serving on client review board for a North Carolina-based pharmaceutical company as the legal representative on the company’s internal committee that reviews advertising and promotional materials.
  • Counseling a California-based pharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.
  • Counseling a Pennsylvania-based pharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.
  • Counseling a New York-based pharmaceutical company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.
  • Counseling a Georgia-based medical services manufacturer on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.
  • Counseling a pharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.
  • Worked with the FDA’s Office of the Ombudsman to help facilitate meetings or discussions between a pharmaceutical company sponsor and the FDA on a stalled clinical development program and when communications broke down.
  • Counseling a California-based biopharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.
  • Counseling a biopharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.
  • Serving on client review board for a Montreal-based pharmaceutical company as the legal representative on the company’s internal committee that reviews advertising and promotional materials.
  • Counseling a Montreal-based pharmaceutical company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.
  • Helped prepare a Citizen Petition, submitted by King Pharmaceuticals, a publicly traded company subsequently acquired by Pfizer, defending a challenge to the company’s sale of an approved drug product; the product remains on the market to date.
  • Represented a number of pharmaceutical clients before local FDA district offices and the FDA’s Office of Compliance to develop proactively a phase-out program of Drug Efficacy Study Implementation (DESI) products before the FDA took enforcement action against the companies.