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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

Of the 55,000 subjects who participated in cancer clinical trials between 2003 and 2016, only 6% were African-Americans, 5% were Asians, and 3% were Hispanics, creating an abysmal minority representation in the data that formed the basis of FDA approval. There are no legal ways for FDA to push sponsors to increase minority representation in … Read more

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