Alan G. Minsk

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 Letters for IPO filings.

Counseling pharmaceutical companies on regulatory issues relating to 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.

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 a California-based biopharmaceutical company on regulatory issues such as 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.

Counseling a Montreal-based pharmaceutical company 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.

Counseling a Pennsylvania-based 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.

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.

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 Georgia-based medical services manufacturer 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 a California-based pharmaceutical 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.

Counseling an Alabama-based manufacturing 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.