The same information submitted on the Form FDA 1571 must be submitted to the UAB RRSC for review in addition to the other information required above. If an investigator comes to UAB from another ...

Principal Investigators on treatment protocols that involve an Investigational New Drug (IND) must complete Form FDA 1572, which the sponsor then submits to FDA. Form FDA 1572 is the contract between ...

The days of waiting for a flu shot at your doctor's office or local pharmacy may be over: The U.S. Food and Drug ...

The U.S. Food and Drug Administration said on Friday it has approved AstraZeneca's nasal spray flu vaccine for ...

The days of waiting for a flu shot at your doctor's office or local pharmacy may be over: The U.S. Food and Drug Admi ...

A CRL is issued by the FDA when it deems that the regulatory application is not complete in its current form. The deficiencies usually that lead to rejection could be the need for additional ...

"At the end of the inspection, a 'Form 483' has been issued with 9 observations. With respect to the mentioned inspection, we have received a letter from USFDA classifying the inspection as ...

The US Food and Drug Administration has given the green light for the first gene therapy that treats a rare form of muscular dystrophy ... with muscle strength. The FDA announced Thursday that ...

The Food and Drug Administration on Thursday approved Amgen's treatment for patients with the most deadly form of lung cancer ...

Some 30 million adults report some form of hearing loss, according to the FDA, which said the impairment could negatively affect one's communication, relationships, performance and well-being.

Following an inspection that ran from July 29 to Aug. 2, the FDA handed Global Calcium a six-observation Form 483. The heavily redacted document was posted online by the U.S. regulator on Wednesday.

FDA Decision Expected by PDUFA Goal Date of October 25, 2024Potential to be First Oral Penem Approved in the U.S.DUBLIN and CHICAGO, Sept. 10, ...