RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.
19 November 2019
The US Food and Drug Administration (FDA) recently warned three drugmakers for good manufacturing practice (GMP) violations and a California-based diagnostic maker for distributing reagents without submitting premarket notification or obtaining pr...

Latest News

ALL
19 November 2019
To help pharmaceutical wholesalers comply with good distribution practice (GDP) inspections, the European Commission on Tuesday released a new aide memoire.
19 November 2019
The World Health Organization (WHO) last month drafted a new guideline on data integrity that explains the important elements to ensure the reliability of data and information in the production and control of pharmaceutical products.
19 November 2019
The US Food and Drug Administration (FDA) said Tuesday that since notifying physicians of particular intra-aortic balloon pump (IABP) device failures last November, two more patients have died and one more serious injury has occurred.
19 November 2019
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
18 November 2019
The US Food and Drug Administration (FDA) on Friday granted premarket approval (PMA) to CooperVision’s MiSight contact lens to slow the progression of myopia, commonly known as nearsightedness, in children ages 8-12.
18 November 2019
The Center for Science in the Public Interest (CSPI), a Washington, DC-based nonprofit, sent letters to the US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) on Monday, calling on the agencies to take enforcement action agai...