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 Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories.

This sponsor will solicit related financial interest disclosures from study PIs and Sub-Is via the FDA Form 1572. The information required to be collected by the sponsor and disclosed by the PI and ...

Release of Drugs for Human Research Use (if any drugs will be used in the protocol) Radiation Safety Approval Infection Control Approval Release of Pathologic Materials FDA Form 1572 2. A member of ...

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 ...

1 strain of the virus. "Today's authorization provides an additional COVID-19 vaccine option," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. Doses are on ...

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 ...

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.

There is an opportunity to fix this by encouraging regulators such as the FDA and the EMA to agree on an aligned regulatory approach to the development of complex generics. In 2021, the FDA and ...

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

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, ...