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
