This week FDA described its heavily hands-on approach for the approval of “Artificial Pancreas” to highlight how FDA reviewers could play an active role in approval of innovative new products. There are several lessons for other developers in this story and notes of caution as well. The automated insulin dosing system, commonly known as an … Read more
Dietary supplements are frequently found to have major quality issues so this should not come as a surprise that another formal study found that about half the products did not contain the active ingredient on the label, about 40% contained other unapproved drugs, about 1 in four products contained products not listed on the label … Read more
The week before Thanksgiving, FDA announced “a comprehensive regenerative medicine policy framework” with great fanfare and it appeared that it is finally going to make significant changes to its policies for regulating stem cells. But a review of this framework shows that it is mostly a rehash of old statements and policies. Four new Guidance … Read more
In the 21st Century Cures Act, FDA is required to accept Real World Evidence (RWE) in support of market approval decisions. However, the RWE is based off the Real World Data (RWD) which is highly variable and hence could impact the acceptability of RWE derived from such RWD. One of the most sought-after RWD is … Read more
Last week FDA announced initiatives that would reduce the direct regulation of most general health genetic tests citing low risk of such tests. A new study published this week raises concerns about incorrect genetic tests of this kind citing specific clinical outcomes linked to the false results. General Health Risk (GHR) tests are designed to … Read more
The recent movie, Passengers, showed a machine that could diagnose diseases, prescribe medications, and perform several complex medical procedures, all without the intervention of a human doctor. It seems real life may be catching up to science fiction sooner than we may think. Over the last year, FDA has slowly eliminated or toned down several … Read more
FDA works hard to create all its Guidance documents but occasionally you come across a master piece, an exceptional Guidance Doc that meets all one could wish for, or at least tries to give everyone everything. In one such Guidance document released this week, FDA presented how diverse food providers such as restaurants, buffet style … Read more
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
