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 ...

FDA officials said an agency review of the available data found oral phenylephrine is not effective as a nasal decongestant ...

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 ...

NT-501 is an investigational ocular implant that utilizes an encapsulated cell-based delivery system to deliver continuous ciliary neurotrophic factor.

The U.S. Food and Drug Administration has proposed to remove oral phenylephrine, widely used in cold and cough syrups, as an ...

Additionally, we continue to actively pursue in-licensing opportunities for clinical-stage assets.” About RAPT Therapeutics, Inc. RAPT Therapeutics is a clinical-stage, immunology-based therapeutics ...

The Food and Drug Administration will allow a new device to be marketed as a treatment for dry age-related macular ...

At the conclusion of the FDA’s inspection of the firm, investigators provided the firm with a Form FDA 483a FSVP Observations. Furthermore, the company’s hazard analysis did not account for ...

"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 ...

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 ...

J&J is the third medtech company to gain U.S. approval for pulsed field ablation, a new atrial fibrillation treatment seeing rapid adoption.

ANI’s Generics business achieved 10.8% year-over-year growth in the third quarter of 2024, driven by strong R&D capabilities ...