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
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
