The print version of Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective is out of stock. Stay tuned for a brand new edition arriving April 2026. You can still purchase an e ...

India@s Central Drugs Standard Control Organization (CDSCO) has introduced draft legislation describing the requirements for informing authorities of manufacturing changes.

Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.

Postapproval Changes for Drugs was developed for regulatory professionals of all levels of RAPS Regulatory Competency Framework, including newcomers and seasoned professionals as well as academics and ...

Comprised of 25 chapters from 30 experts from seven different countries, this edition incorporates a global overview of regulatory intelligence.

The European Medicines Agency (EMA) said it recommended approval of more than a hundred new drugs in 2025, of which about 40% were for new active substances that had not previously been authorized in ...

The Regulatory Affairs Professionals Society (RAPS) and the Parenteral Drug Association (PDA) are proud to collaborate on a dynamic networking event at Drake’s Brewing Company. This gathering is ...

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.

Finding your way through the regulations, state-of-the-art standards, and interpretations applicable to health software, and, in particular, software as a medical device (SaMD), can be challenging.

RAPS Regulatory Intelligence Conference is designed to explore key topics more in-depth, creating a collaborative environment for engaging education and professional development.

Need help recalling and understanding regulatory concepts? RAPS has the tool for you, whether you are studying to take the RAC exam or you want to sharpen your knowledge of regulatory terminology.