Data Submission News Today

The health regulator sought certain additional data to satisfy requirements pertaining to chemistry, manufacturing, and controls before the treatment, called pz-cel, can be approved, in its so-called "complete response letter". The drug developer is seeking approval for the treatment in patients with recessive dystrophic epidermolysis bullosa, where the skin becomes fragile and blisters can appear through rubbing or exposure to heat. FDA in its response letter indicated that the prop...

/PRNewswire/ - On March 20, Claigan Environmental Inc. (www.claigan.com) will be hosting an informative webinar dedicated to navigating the complexities of...

The final rule applies to certain employers in high-hazard industries with 100 or more workers.

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People may not realize that the key to the successful implementation of a policy is the availability of excellent one-door integrated data in order to avoid ...

Last minute and say go now, so this was a recommendation to look at this seriously but very much depending on fda which is the goal standard for assessing safety and efficacy and cdc. fda will have a meeting on september 17th and look at the pfizer booster data. thatll be very important. i gather that data looks pretty good. we will see what they say but moderna is a little behind. they havent gotten their data fully submitted with, likewise j&j, a little behind. its the responsible thing to do ...