Feb. 27, 2017

Vol. 14 No. 38

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TGA Looks to Replace ‘Burdensome’ Requirements for Distributing Unapproved Drugs

The TGA would no longer have to process thousands of applications for access to unapproved drugs. Read More

FDA Clarifies ICH Guideline on Selecting and Justifying Drug Manufacturing Starting Materials

The draft guidance covers the implementation of a single section of the Q11 manufacturing guideline.  Read More

FDA Cites API Maker for Data and Label Discrepancies

Inspectors found inadequate maintenance of testing data. Read More

FDA Awards Second Orphan Drug Designation to Zymeworks for ZW25 in Gastric Cancer

ZW25 is an antibody intended as a treatment for patients with a tumor expressing HER2. Read More

EMA to Expand Scope of Transparency Policy to Cover Corporate Documents

The EMA is proposing to grant the public access to certain corporate documents. Read More