The Goldwater Institute, a think tank lobbying for the expanded access to experimental drugs, commonly known as the Right-To-Try Legislation, sued FDA to disclose the regulatory processes used to release an experimental Ebola drug to a few patients in the US during last year’s Ebola outbreak. In August 2014, FDA allowed use of Zmapp, an … Read more
In the first quarter of 2014, a drug Hetlioz was approved by the FDA. It’s used to treat non-24 sleep-wake disorder, it’s a rare health condition related to sleeping issues that completely offset the internal body clock. However, according to a consumer advocacy group the agency mistakenly widened the market beyond its anticipated limits. In … Read more
Cholesterol lowering is linked to lower risk of cardiac episodes and is very well managed by treatment with a class of drugs called statins that include Lipitor, Zocor, etc. Lipitor and other statins are now available as cheap generic drugs and have a very well-established safety and efficacy profile. So, there was obvious skepticism to … Read more
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
