Meeting Details:

The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the TransMedics Organ Care System (OCS) Heart, by TransMedics, Inc. The proposed Indication for Use for the TransMedics OCS Heart, is as follows: The TransMedics Organ Care System (OCS) Heart System is a portable extracorporeal heart perfusion and monitoring system indicated for the resuscitation, preservation, and assessment of donor hearts in a near-physiologic, normothermic, and beating state intended for a potential transplant recipient. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

Meeting Details:

The committees will discuss biologics license application (BLA) 761130, tanezumab subcutaneous injection, submitted by Pfizer Inc., for the proposed indication of relief of signs and symptoms of moderate to severe osteoarthritis in adult patients for whom use of other analgesics is ineffective or not appropriate. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

Meeting Details:

The committee will discuss and make recommendations regarding the benefits and risks of dermal fillers concerning the following topics: (1) risks associated with intravascular injection of dermal fillers and (2) patient preference and informed decision making. FDA is convening this meeting to seek expert opinion on the clinical evaluation and regulation of dermal filler products. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.