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Yesterday FDA took an unprecedented action of filing complaints in Federal courts seeking permanent injunctions to stop two stem cell treatment groups from selling stem cell products, a decision that affects more than 100 clinics in almost 40 states. These two groups were in the news last August when they were raided by FDA inspectors … Read more

FDA wants to encourage food manufactures to be able to claim the health benefits of their products. Claims about the nutritional properties of food and ability to reduce the risk of health-related conditions can be made. This is a new and significant development. In the past , FDA had objected when food manufacturers claimed that … Read more

This Friday, the 4th of May 2018 is the last day FDA will accept most submissions to CDER and CBER and several to CDRH in paper format. Starting 5th of May 2018, almost all INDs, market approval applications, most DMFs, except Type III DMFs, can only be submitted electronically. Also all amendments, request for meetings, … Read more

Last week Senator Chuck Grassley of Iowa sent a letter to FDA asking about the outcome of a Warning Letter issued last year to a stem cell clinic and in the process raised issues that could affect regulation of all similar clinics by FDA. In August 2017, FDA issued a Warning Letter to US Stem … Read more

Since the inception of the Breakthrough Therapy Designation (BTD) program over 5 years ago, FDA granted this designation to 63 products, and approved 17 products under this program. But it also took back the designation from 14 of them, 5 in last year alone. That’s a whopping 22% of the BTDs; more than 1 out … Read more

This week FDA rescinded a previous decision to refuse-to-file (RTF) an NDA from Alkermes for a depression drug without the company addressing any of the deficiencies and additional data requirements listed by FDA at the time of the RTF. The company released a statement claiming that the reversal of the FDA’s decision came about due … Read more

There is a general perception that FDA regulations are overly burdensome, FDA takes long time to approve new treatments, and patients can benefit from treatments based on anecdotal data. This led to some laws passed at the state level solely intended to undermine FDA’s oversight. But these states and patients may soon face buyer’s remorse. … Read more

FDA plans to accept 510k applications for medical devices that show compliance with FDA defined standards rather than direct comparison to the predicate device by expanding its abbreviated 510k program under the least burdensome philosophy. FDA will release a list of 510k devices that could use this new program along with consensus standards and expected … Read more

Two new FDA guidance documents discuss the practical and regulatory aspects of testing new products in children and pregnant women confirming the well-established industry practices for these populations. Both documents emphasize the need to test new drugs in children and pregnant women only when absolutely necessary and to use alternate data sources to reduce clinical … Read more

FDA recently published the time-lines for the pre-approval GMP inspections for drugs and medical devices and it shows some useful time-lines for regulatory actions that may be useful to all manufacturers planning for such inspections. Prior to approval of any new drug or medical device, FDA must conduct a GMP audit of the facility where … Read more