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USFDA Guidance: Container Closure Systems for Human Drugs and Biological Products
As pharmaceutical products become more complex, the container closure system (CCS) plays an increasingly important role in maintaining the safety, quality, stability, and performance of a drug product. Packaging is not simply a means of containing a medicine—it can directly influence product quality through interactions between the drug, packaging materials, manufacturing processes, and storage conditions. The U.S. Food and Drug Administration (FDA) has issued the draft guida
Sharan Murugan
3 days ago4 min read
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Formal meetings between the U.S. Food and Drug Administration (FDA) and sponsors or applicants can play an important role at critical points in drug and biological product development. These interactions provide an opportunity for sponsors to obtain regulatory advice, discuss development challenges, clarify specific issues, and support efficient planning of development and regulatory submissions. The FDA’s August 2026 guidance, Formal Meetings Between the FDA and Sponsors or
Sharan Murugan
3 days ago7 min read
UK MHRA Guidance: Finding Product Information About Medicines
Access to accurate, up-to-date information about medicines is important for healthcare professionals, patients, and anyone seeking to understand how a medicine should be used safely. Product information provides details about the use of medicines, their properties, and the scientific basis for marketing authorisations. The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance, Find product information about medicines, to explain how users can acc
Sharan Murugan
3 days ago4 min read