Guideline News
New Clinical Trials Regulation comes into effect in the EU
Regulation (EU) No 536/2014, known as the Clinical Trial Regulation (CTR), comes into effect in the...
Read more
EMA publishes reflection paper on forecasting demand for medicinal products in the EU/EEA
The EU Executive Steering Group on Shortages of Medicines Caused by Major Events has adopted a reflection paper which contains...
Read more
FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain
U.S. Food and Drug Administration is finalizing two guidance documents and making available two draft guidance...
Read more
FDA Publishes Draft Guidance on Oral Drug Products Administered Via Enteral Feeding Tube
The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled...
Read more
FDA updated its guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19
FDA updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section...
Read more
EU Authority writes to MA holder with regards to Azido impurity in irbesartan
Co-Ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has written to a marketing...
Read more
USFDA publishes guidance for Bispecific Antibody Development Programs
U.S. Food and Drug Administration issued a final guidance, Bispecific Antibody Development Programs. This final guidance provides...
Read more
Pharmeuropa publish revised version of general chapter 2.9.19. Particulate contamination: sub-visible particles
A new, revised version of general chapter 2.9.19. Particulate contamination: sub-visible particles has been published in Pharmeuropa 33.2. In addition...
Read more
US FDA issues guidance for ANDAs for Certain Highly Purified Synthetic Peptide Drug Products
On May 19, 2021, the FDA finalized the guidance for industry entitled “ANDAs for Certain Highly...
Read more
FDA Issues Final Guidance on Demonstrating Bioequivalence for Soluble Powder Animal Drugs
On May 20, 2021, the FDA issued final guidance for industry (GFI) #171 entitled “Demonstrating Bioequivalence...
Read more
Recent News
