Despite a well-known and scientifically accepted practice of using blinded studies to support a claim, it is still not uncommon for well-intentioned researchers to conduct open-label studies leading to highly biased results. In an article published in the PLOS journal by three Australian researchers, a review of 960 peer-reviewed articles in 5 different animal behavior journals found that … Read more
Some Warning Letters demonstrate that quality of training of FDA Inspectors. FDA Inspectors are trained to pay close attention to seemingly minor observations to catch errant manufacturers. Recently, in a Warning Letter issued to a manufacturer of oxygen tanks, Trans Ox located at West Columbia, South Carolina, FDA inspectors identified several discrepancies in documents and gross violations … Read more
Since the launch of the Breakthrough (BT) designation program by FDA in July 2012, there have been more than 200 requests for this designation just to CDER, along with several additional to CBER. FDA granted about one-third of the requests, and rejected the other applications for either lack of clinical evidence, safety issues, or no significant improvement … Read more
Whenever a new drug is disapproved, FDA issues a complete response letter (CRL) to the manufacturers citing all the reasons why it was rejected. These letters contain details of the applicant’s development program with specific deficiencies identified and potential solutions offered. The CRL becomes the roadmap for the applicant to satisfy FDA’s concerns and eventual … Read more
In its efforts to rein in drug advertisement in the digital age, FDA has published several guidance documents and rules to clarify and advise about acceptable marketing practices. There is a guidance on use of website content and twitter among others that advise about FDA’s expectations. However, there is little advice from FDA about adequate digital ads such as … Read more
When FDA audits a company and find smajor deficiencies followed by publicly disclosing its findings, other regulatory agencies in the rest of the world also take notice. Hospira learnt it the hard way recently when Health Canada banned products manufactured at Hospira’s facility in Italy specifically citing the “reliability of the laboratory data” and FDA’s … Read more
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
