Last week at a conference on real world evidence (RWE) organized by the National Academy of Sciences in Washington DC, the FDA Commissioner, Dr. Gottlieb, and The CDER chief, Dr. Woodcock, emphasized the limitation of conventional clinical trials and the importance of RWE, promising new guidance documents and new regulatory paradigms to increase the use … Read more
This week FDA issued 13 Warning Letters to online pharmacies selling prescription drugs without prescription, drugs long taken off the US market for safety reasons, and selling drugs that were never approved in the US. These Warning Letters cite hundreds of websites, mostly hosted from outside the US. It does not seem like FDA’s action … Read more
Can FDA be forced to recognize un-proven stem cell therapies due to pressure from States? Will the state laws curtail development of FDA-approved stem cell therapies? A stem cell clinic is one that offers a product containing enriched stem cell preparations to patients for treating a variety of indications. This month a new law came … Read more
It has been argued that because expedited approval pathways allow drugs to be approved with incomplete analysis of safety and efficacy, it potentially leads to new drugs with limited benefit and/or with potential safety concerns. But this is a simplistic one sided argument that does not address the context in which such drugs are approved. … Read more
Why are drugs expensive; is it because the cost of developing new drugs is very high, or that there are onerous regulatory processes for market approval, or may be it takes too long to develop a new drug? And if all these were addressed would it lead to cheaper drugs? This week the FDA Commissioner … Read more
Real World Evidence (RWE) and Real World Data (RWD) are very important but distinct aspects of the clinical use information available for a drug. The 21st Century Cures Act mandates FDA to use RWE in support of the approval of a product and FDA’s opinion about the utility of such data in support of market … Read more
FDA and EMA signed a mutual confidentiality arrangement this month which commits both agencies to share all information about manufacturing operations located in either region including trade secret and non-public information. The agreement will become effective on 1 Nov 2017 and will be in transition phase till July 2019 giving both agencies time to work … Read more
Do online diagnostic tests qualify as FDA-approved diagnostics, it seems not. Last week Google partnered with a mental health group to offer an online tool for diagnosis of clinical depression; every time someone searches on Google for clinical depression, he/she will be suggested to try out the online tool to find out if he/she suffers … Read more
This week, FDA’s Commissioner made a detailed announcement about regulation of adult stem cells which caught everyone’s attention but it lacks specifics and does not indicate a change in the existing rules for the regulation of stem cell clinics. Adult stem cell therapies are available freely in the US from hundreds of providers. There are … Read more
In a new guidance document released by FDA practically every party that is involved in any aspect of the manufacture, distribution, shipping and handling of drugs and biologics will be required to register either with the FDA directly or with a state regulators where they operate. Several new parties are added to the registration requirements … Read more
