Prahsant Kumar FDA routinely uses “Untitled Letters” which are akin to Warning Letters but are issued when FDA does not have a clear violation description since these violations were identified by measures other than an audit. These letters which are often released to the public at the same time they are sent to the accused company could have a … Read more
Despite the approval given by the government, the insurers can refuse to cover a given device. This was emphasized by the case of Linx, a new medical implant for treatment of severe acid reflux. The device was approved by FDA about 3 years ago and is reimbursed by the Center for Medicaid and Medicare Services … Read more
FDA has proposed some amendments in the existing regulations on over-the-counter drugs and fixed-combination prescription. According to the current regulations, it is the responsibility of the sponsor to make sure that in a fixed combination drug, each of the ingredients should make some contribution towards the claimed effects of the product. The proposed regulation would simplify the … Read more
n an article published this week in Nature Drug Discovery, FDA senior officials reported that of the cancer drugs that failed to gain market approval in the last decade, about one-third were rejected by FDA due to defects in the clinical trial design, while the rest were unsuccessful because the drug failed to show FDA-acceptable efficacy … Read more
On May 18th, FDA issued a draft guidance on Adaptive Design for Medical Device Clinical Studies.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
