Biosimilars: Fact and Fiction

The FDA issued draft guidance on biosimilar product development.  To date, there are no biosimilars in the U.S. market because they were considered “too complex” to include in the 1984 Hatch-Waxman legislation, which regulates the generic drug industry in America. ...

FDA approves Cialis to treat benign prostatic hyperplasia

The U.S. Food and Drug Administration today approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when...

FDA Outlines Plans for an Outside Network of Scientific Experts

FDA’s Center for Devices and Radiological Health (CDRH) is soliciting comment on a plan to create a network of outside scientific experts who would provide staff with rapid access to specific specialized knowledge about emerging technology, as well as other topics. To...