Health Authority Updates

August 9, 2023
Food Supplements
South Korea Approves the First Physically Recycled PET Containers for Food and Beverages
January 6, 2023
Medicinal Products,
Publishing and Submission
Failure to Respond to an ANDA CRL – What Does the FDA Guidance Say?
November 29, 2022
Medicinal Products,
Labeling
US FDA Releases Draft Guidance on Content and Format of Labeling for Non-prescription Drugs
September 22, 2022
Medicinal Products,
Regulatory Affairs
Nitrosamine Impurity Confirmatory Testing by MAHs
May 20, 2022
Medicinal Products,
Publishing and Submission
Promotional Material – FDA’s Electronic and Non-electronic Format Submission Guidance
April 4, 2022
Medicinal Products,
Medical & Scientific Communication
PAAB Complements the Standard
Pre-clearance Pathway with Accelerated Review Options (AROs)
March 31, 2022
Medicinal Products,
Labeling
EMRN Adopts a Common ePI Standard for Medicines in the EU
March 29, 2022
Medicinal Products,
Regulatory Affairs
US FDA's Final Guidance on Population Pharmacokinetics
March 8, 2022
freya fusion
DADI: An Upcoming Regulatory Business Transformation Project from the EMA
February 21, 2022
Medicinal Products,
Medical & Scientific Communication
Comparative Analysis of TGA’s 2018 and 2021 Advertising Codes
February 17, 2022
Medicinal Products,
Regulatory Affairs
Nitrosamine Risk Assessments & FDA’s Alternate Methods to Reduce Impurity Levels
December 15, 2021
Medicinal Products,
Publishing and Submission
Converting CAPs to UK MAs – Deadline and a Few Points to Remember