• What is Current Good Manufacturing Practices Compliance (cGMP)?

    What is Current Good Manufacturing Practices Compliance (cGMP)?

    In the United States, Current Good Manufacturing Practices (cGMP) are the Food and Drug Administration’s (FDA) formal regulations regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities. The word “current” was added to signal to companies that they needed to remain up to date with the latest technologies, not rely on what was a good practice ten years ago.cGMPs are followed by pharmaceutical and biotechnology companies to ensure that their items are manufactured to specific requirements including identity, strength, quality, and purity. Good Manufacturing Practices are regulated... Read More

  • The FDA’s Race To Catch Up With Digital Medicine

    The FDA’s Race To Catch Up With Digital Medicine

    The Food and Drug Administration announced an initiative in June, which would ramp up regulations in the digital health space. The announcement comes close after the 21st Century Cures Act which, among several proposals, starts to outline the role of FDA in overseeing digital health.It further clarified its plans with regard to regulation of digital health technologies in a new blog post last July. The most notable announcement was the new Pre-Cert for Software Pilot Program.The pre-cert program has important inclusion criteria that limit participants to those developing a “software product that meets the definition of a medical... Read More