Month: May 2016

A massive new study of drug candidates sheds light on which experimental therapies are most likely to eventually reach the market. The report was compiled by biotech’s largest trade association, the Biotechnology Innovation Organization (BIO), with the help of business intelligence firms BioMedTracker and Amplion, and it found that drugs for blood disorders have the …

Cancer Drugs Are The Least Likely to Receive FDA Approval Read More »

Agency warns that serious adverse effects generally outweigh benefits for patients with sinusitis, bronchitis, and uncomplicated UTIs. FDA announced that it will require drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated with new safety information. FDA is warning that serious adverse effects with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients …

FDA issues safety alert for fluoroquinolones Read More »

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products. First, however, a little bit of historical context might be helpful.  In late 2013 Congress passed a law called the Drug Quality and Security Act (DQSA).  Among other things, DQSA created …

New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations Read More »