In 2004, the FDA issued a guidance document, entitled “Premarket Assessment of Pediatric Medical Devices.” The guidance stated that, when consistent with scientific principles, data can be...
On May 10th the Food and Drug Administration (FDA) published a final rule expanding regulation to a range of products that meet the statutory definition of a “tobacco product,” including...
In September 2007, the Prescription Drug User Fee Act (PDUFA IV) was reauthorized and expanded, broadening and strengthening FDA’s drug safety program. As part of PDUFA’s reauthorization, the Agency...
Compensating Controls: “A safeguard or countermeasure, external to the device, employed by a user in lieu of, or in the absence of sufficient controls that were designed in by a device manufacturer,...
Over the past several years, outsourcing within the pharmaceutical supply chain has become common. The rise of the “virtual” pharmaceutical company has resulted in a complex supply chain, with the...
On January 4, 2016, the FDA published a draft guidance entitled, “Unique Device Identification: Convenience Kits.” The draft guidance comes after the Agency’s 2013 final rule that established a...
What to do if you experience delays in obtaining IND-related feedback from the FDA: In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations...
The FDA publishes weekly enforcement reports highlighting drugs that have been recalled during the previous week. Over the past several months these reports have been littered with hundreds of...
Regulatory Sciences
Recently, biosimilars have made a definite appearance on the FDA’s radar, an expected result after the first biosimilar product gained FDA approval in March and the FDA’s release of four final...
On November 9, 2015, FDA launched the Orange Book Express application, which provides a list of the drug products approved by the FDA. What is the Orange Book? The Drug Price Competition and Patent...