Compliance

The Importance of Purified Water Systems in the Pharmaceutical Industry

June 13, 2024

By Mark Land, MS, RAC-US, AAHP President My first experience with a water treatment system was a double deionization, pre- and post-filtration technique. There was no storage or recirculation. It…

Compliance Efforts — Where to Put One’s Priorities?

June 13, 2024

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Present Foresight to Protect the Future

May 9, 2024

By Mark Land, MS, RAC-US, AAHP President AAHP planned this issue of the newsletter to focus on stewardship several months ago as part of our annual editorial calendar. I knew…

Quality/Regulatory Support of New Product Introductions

April 16, 2024

By Mark Land, MS, RAC-US, AAHP President The introduction of a new product at retail is a team effort. Meeting technical information requirements to support a new product introduction is…

FDA Issues FY23 Drug Safety Priorities Report 

April 12, 2024

In February 2024, FDA’s Center for Drug Evaluation and Research (CDER) published its ninth yearly report describing key safety programs and activities, and illustrating the depth and versatility of drug…

The Homeopathic Pharmacopoeia of the United States

March 14, 2024

By Mark Land, MS, RAC-US, AAHP President The Homeopathic Pharmacopoeia of the United States (HPUS) is the legal basis for marketing homeopathic drug products in the United States and many…

FDA Guidance Document Development Process 

January 23, 2024

By Alvin J. Lorman, AAHP Counsel The Food and Drug Administration (FDA) is seeking public comment on a draft “Report and Plan on Best Practices for Guidance.” Guidance documents, rather…

Increased FDA Scrutiny of Eye Care Category 

September 18, 2023

By Alvin J. Lorman, AAHP Counsel  The Food and Drug Administration (FDA) last week continued its heightened surveillance on ophthalmic drug products sold without FDA approval or without complying with…

FTC Proposes Rule Against False or Misleading Consumer Reviews and Testimonials

August 22, 2023

By Alvin J. Lorman, AAHP Counsel   The Federal Trade Commission (FTC) has announced that it is moving forward with a proposed Trade Regulation Rule that is intended to prevent fake,…

FDA Cracks Down on Testing for Glycerin Contaminants — Again

June 13, 2023

By Al Lorman, AAHP Counsel  The Food and Drug Administration (FDA) has begun another campaign to protect consumers from products that contain glycerin potentially contaminated with diethylene glycol (DEG) or…

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