iwewlkws

On May 18th, FDA issued a draft guidance on Adaptive Design for Medical Device Clinical Studies. This is the first time FDA formally endorsed the use of use of adaptive clinical trial design for medical devices. This guidance follows a previous guidance for use of adaptive clinical trials for testing drugs and biologics released more than 5 years ago. Together … Read more

FDA strictly enforces prevention of off-label promotion of products. In the recent past, there have been numerous cases of FDA’s punitive actions against companies and individuals accused of off-label promotion. US courts have repeated sided with FDA in agreeing that off-label promotion is not protected by free speech rights. Now Amarin Corporation, the manufacturer of … Read more

Certain infusion pumps such as Hospira LifeCare PCA3 and PCA5, used to supply of therapeutic and anesthetic drugs are controlled by software that communicates remotely with controllers and wireless networks. Such systems create a potential security vulnerability of hacking into the device and altering operation. Though so far there have been no reports of unauthorized … Read more

In a recently published report from the Office of the Inspector General (OIG), in the last 2 years, FDA has increased GMP inspections of generic drug manufactures by almost two-thirds. About 90% of these inspections were surveillance inspections in which FDA randomly inspected facilities for compliance with GMP. FDA focused its inspections on “high risk” sites and … Read more

FDA issued a proposed rule of 1 May 2015 to revise a previous law from 20 years ago regulating over-the-counter (OTC) antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital. Hand cleaners are generally recognized as safe and effective, however recent scientific data has cast … Read more

Food facilities are not expected to report to FDA incidences of contamination unless they suspect that the contaminated food has entered distribution. Hence most food contamination found during manufacture are not reported to the FDA. Recent outbreak of listeria contamination at Blue Bells plants exposed this gap between expectation from and the reality of enforcement … Read more

This week FDA posted a review of its drug approval process based on the principle of benefit-risk-assessment that shows it gives special consideration to new molecular entities (NMEs) intended for diseases with few or no treatment options with regards to market approval decisions. Over the last decade, FDA emphasized the value of putting the safety … Read more

Duodenoscopes are widely used reprocessed devices for ERCP. Improper cleaning and disinfection of duodenoscopes is the cause of several incidences of infections including MRSA episodes annually. At a recent FDA Advisory Committee meeting, the risk and safety issues related to these devices were discussed. The gastroenterology and urology devices advisory panel of FDA observed that … Read more

This week FDA’s Arthritis Advisory Committee recommended approval of Remsima, a biosimilar product to Remicade. Remsima was developed by South Korea’s Celltrion. Remicade is one of Janssen’s biggest products with annual revenue of about $7 billion. There are several firsts in this decision. This is the first biosimilar to a monoclonal antibody reviewed by an FDA advisory … Read more