We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA wants to see both efficacy and effectiveness data in future postmarket filings to better conform to International Conference on Harmonization standards. Read More
Trade organizations appear satisfied with the FDA’s proposed goals for the next iteration of PDUFA, citing a bevy of enhancements to drug development. Read More
The FDA has handed Infusion Options a warning letter for a slew of GMP deficiencies in compounding sterile products and failing to meet 503B conditions for outsourced compounding operations. Read More
The FDA has zeroed in on five dietary supplement makers in recent weeks, complaining of a laundry list of issues that range from promotional claims to GMP problems. Read More