The introduction of high-quality and reasonably-priced generic drugs in the market is a prevalent challenge for multiple Health Authorities. Several countries are taking steps to address this issue and make more generic drugs available in the market, consequently increasing the competition at a global level.

In September 2022, the United States Food and Drug Administration (US FDA) released a draft guidance document titled “Statement of Identity and Strength - Content and Format of Labeling for Human Non-prescription Drug Products.” The draft guidance aims to enhance the consistency of labeling for Over-the-Counter (OTC) drugs. It addresses the statement of identity and drug strength for OTC products.

Advance Therapy Medicinal Products (ATMPs) are novel drugs that meet patients’ specific needs. But they drastically increase the cost of treatment. Generic alternatives provide relief in terms of treatment cost with a quality drug of similar effectiveness.

Pharmaceutical advertising, including direct-to-consumer advertising, is regulated by the United States Food and Drug Administration’s (US FDA) Office of Prescription Drug Promotion (OPDP), Advertising and Promotional Labeling Branch (APLB) at the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) respectively. The information submitted to the OPDP and the APLB must be accurate, ethical, and non-misleading. Additional information about the product’s benefits and risks must be included in the submission.

Do you know? One can save up to a million in the coming three (03) years by introducing Computer Software Assurance (CSA) in place of the existing Computer system validation (CSV) model!

Over the years, pharmaceutical organizations have incorporated CSV, a risk-based validation approach to ensure computer operating systems are at par with Regulatory requirements.