The FDA issued final guidance Tuesday for outsourcing facilities on compounding and repackaging radiopharmaceuticals, along with draft guidance on insanitary conditions at compounding facilities. Source: Drug Industry Daily
The FDA issued a warning letter to Wilson Medicine Company citing serious quality problems found during a Feb. 26-March 1 inspection of its OTC manufacturing facility in Nandore, India. Source:…
The EMA lowered its estimate for the number of centrally authorized drugs that may face post-Brexit supply disruptions from 108 to 39 — including 25 human medicines. Source: Drug Industry…
Against a backdrop of declining sales for its branded hepatitis drugs, Gilead announced plans to launch its own “authorized generics” of two of its hep C treatments. Source: Drug Industry…
It cost an average of $19 million to get new drugs through their pivotal clinical trials and onto the market, a new analysis has found. Source: Drug Industry Daily
The FDA rapped Umicore Argentina for violations relating to its control procedures and equipment calibration, following a May inspection of the API manufacturer’s Buenos Aires facility. Source: Drug Industry Daily
The FDA released two new guidances Monday to help speed reviews of generic drugs and get the products to market more quickly. Source: Drug Industry Daily
Genentech and Boehringer Ingelheim want the FDA to amend or clarify parts of its draft guidance on the use of liquids or soft foods as drug administration vehicles. Source: Drug…
In the latest development in the ongoing saga over Allergan’s transfer of Restasis patents to a Native American tribe, the partners sued Amneal for infringing upon two patents for the…
The EMA’s Committee for Medicinal Products for Human Use recommended 13 drugs for human use at its September meeting. Source: Drug Industry Daily