For many drugs, the mechanism of action is either unknown or not confirmed. In an assay published in The Scientist, three case studies were used to emphasize why it is not critical, if not required, to know the mechanism of action of a given drug. Three drugs used as case studies were the CNS drug lithium, … Read more
This week Philips Healthcare announced release of a smart watch very similar in functionality and appearance to Fitbit, Apple’s iWatch or Samsung Gear watch. However, the Philips watch has one difference from its competition; it is registered with the FDA as a medical device. Smart watches are not considered medical devices by FDA and do not require registration or … Read more
An email leak from a Democratic National Committee (DNC) led to the Chair of the DNC losing her job and the leader of the party barely surviving a major crisis on the eve of the convention. This followed concerns of security of personal and official emails. This episode highlights once again the high-risk of electronic … Read more
Negative audit findings make headlines every time a site in India is found to be in violation of GMP requirements by US FDA. For the last few years, negative news about drug manufacturing facilities in India dominated public discourse so much that it has become a cliché to use findings at sites in India for … Read more
Biologics manufacturing facilities using traditional stainless-steel bioreactors have to deal with significant manufacturing suite unavailability between production cycles due to expensive cleaning technology, extensive cleaning validation, and the associated loss of productivity and revenue. The use of single-use and disposal technologies such as single-use bioreactors (SUB) can greatly increase the production efficiency by reducing the … Read more
A review of the payments to physicians posted on the CMS Open Payment website indicates that there has been no decrease in the payments to physicians by companies. In 2015, drug companies paid $7.52 billion just like the $7.49 billion paid last year to more than 600,000 physicians of almost all kinds of specializations. The list of … Read more
Last year, during the drug pricing debate triggered by Turing Pharma’s Martin Shkreli, a San Diego compounding pharmacy Imprimis Pharmaceuticals announced that it would offer a cheap compounded version of the expensive FDA-approved drug. At that time, we criticized Imprimis based on our belief that such a practice will jeopardize all approved drugs. This week FDA confirmed … Read more
A new draft Guidance Document on “Gifts to FDA” could be one of the strangest documents of its kind released by the Agency in its history. The document defines a “gift” to the FDA and then details the various rules that would govern the evaluation and acceptance of such gifts. Only the FDA Commissioner is … Read more
Last month, FDA held a public hearing to collect public opinions about enacting a new user fee for over-the-counter (OTC) drugs. The presenters at the hearing could be divided into three groups with distinct preferences. The FDA was the host of the hearing and a strong proponent of the OTC user fee giving several reasons why a user fee … Read more
In his State of the Union address this year, President Obama announced the “Cancer Moonshot” of the US government whereby multiple aggressive initiatives were launched to find cures for cancer. Over the last six months, numerous initiatives have been announced to encourage research, increase patient participation in clinical trials, and expedite the approval of new cancer drugs. … Read more
