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The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More
In a new enforcement initiative intended to boost drugmaker quality, the European Medicines Agency (EMA) has begun publishing the names of manufacturing facilities that fall out of compliance with good manufacturing practices (GMP). Read More
The FDA has extended by 60 days the comment period for its proposed safety labeling rule for generic drugs. Stakeholders now have until March 13 to comment on the proposal, which would allow generic drugmakers to update labels in response to safety issues without agency approval. Read More
The FDA is bringing the citizen petition process into the 21st century by allowing for electronic submissions, the agency says in a Federal Register notice published today. Read More
HHS stands by its final rule expanding the discounts for orphan drugs that hospitals and healthcare providers can apply when used to treat non-rare diseases, the agency said in a court filing opposing PhRMA’s attempts to invalidate the rule. Read More
To satisfy new Australian guidance on supplier qualification for raw materials, drugmakers need to stop using one-size-fits-all questionnaires and adopt screening methods that are specific to the products they are making. Read More
The FDA does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing last week that outlines how it intends to approach one contentious issue involving compounders. Read More
While breakthrough therapy designation for new drug products has taken off dramatically at CDER, the FDA’s CBER has not moved quickly to approve applications for the new designation. Read More