iwewlkws No one is above the law, including government run facilities. The National Institutes of Health (NIH) facility in Bethesda, Maryland, which manufactures injectable drugs for clinical trials being conducted at NIH hospitals with NIH funding, was found in violation of several GMP regulations by FDA’s inspectors. The deficiencies identified include albumin vials used for administering interleukin to be … Read more
After getting rejected twice by FDA and once by the independent Advisory Committee, the female libido drug flibanserin, commonly called Pink Viagra, finally won recommendation for approval by the Advisory Committee with FDA’s decision coming in August. The drug has very limited benefits with clinical trial participants expressing one half to one additional sexual episode compared to placebo. … Read more
FDA announced a much anticipated schedule for mandatory electronic submission of most market approval applications (NDA, BLA, ANDA, DMFs, etc), and INDs. In a new Guidance Document released on 15 May 2015, FDA will only accept NDA, BLA, ANDA, and Master Files via its electronic submission gateway (ESG) in the CTD format starting 15 may 2017, and … Read more
Direct-to-Consumer Ads are targeted to individual patients and try to address issues that affect a given patient highlighting the benefits and risks of drugs. The assumption usually is that a patient will make his or her own decision regarding pursuing prescription of the product in the drug advertisement. However, in real life, patients likely discuss … Read more
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
