iwewlkws In an announcement this week, FDA classified most predictive genetic tests to be 510k-exempt. This is a remarkable about-turn for the Agency who till recently viewed genetic tests to be high risk devices that need 510k or even PMA approval. Last year only FDA first announced and then suspended a decision to strictly regulate genetic … Read more
In early September, FDA and EMA announced that they will start recognizing each other’s GMP audits and starting Nov 1 FDA announced that it has started this with eight European countries. As of 1 Nov 2017, if a manufacturing site passed an audit by regulators from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the … Read more
Physicians are increasing frustrated with the increasing complexity of clinical trials, in their opinion, and the seeming duplication of work that could be avoided by better use of available technology. A commentary published in MedScape by Dr. John Marshall of the Lombardi Comprehensive Cancer Center at the Georgetown University Hospital highlights several common clinical trial … Read more
Physicians are increasing frustrated with the increasing complexity of clinical trials, in their opinion, and the seeming duplication of work that could be avoided by better use of available technology. A commentary published in MedScape by Dr. John Marshall of the Lombardi Comprehensive Cancer Center at the Georgetown University Hospital highlights several common clinical trial … Read more
About two-thirds of drugs approved as orphan drugs in the last 20 years did not get subsequent approval for other indications, and only 6 orphan drugs out of the 451 approved by FDA ended being top-selling drugs. Conventional wisdom in the industry has been that orphan designation could be the proverbial foot-in-the-door to get subsequent … Read more
This week FDA published the updated inspections manual which does not contain any obvious major changes to the previous version. Earlier this year FDA’s Office of Regulatory Affairs was reorganized to improve the quality of inspections. However, the inspections manual does not reflect those changes. The “Investigations Operations Manual”, also known as the Audit Manual, … Read more
Last month FDA sent a Warning Letter citing GMP and labeling violations to a bakery based in the suburbs of Boston which could be perceived by many to be an example of overkill by the Agency auditors, and is some ways it is. The most outrageous statement in the FDA letter was to ding the … Read more
About half of the physicians who participate in clinical trials do only one trial, never doing another one. About half of the investigators in clinical trials are new, doing their first, and possibly last, clinical trial. Doctors do not do second trials because of the extra work and time needed to conduct a trial and … Read more
In a new guidance released this week FDA revised the CTD and eCTD formats of market approval applications for drugs and biologics (NDA, ANDA and BLA) with the intent to simplify the documents and provide higher flexibility for organizing content. FDA also withdrew two previous guidance documents that described detailed granularity instructions giving excruciating details … Read more
California passed a law this week that requires physicians providing unapproved stem cell therapies to prominently display at multiple locations within the clinic that the stem cell therapy provided by them is not approved by FDA. The intent of the new law is to assure that patients are aware of the unapproved status of the … Read more
