PLOS: DNA Science

JUNE 1, 2023

DEB has been a candidate for a gene therapy since 2002. “Until now, doctors and nurses had no way to stop blisters and wounds from developing on dystrophic EB patient skin and all we could do was to give them bandages and helplessly watch as new blisters formed. RDEB is inherited from two carrier parents.

FDA Approval 52

FDA Approval Therapies FDA Disease 52

Drug & Device Law

JUNE 13, 2022

2002), which rejected a Georgia plaintiff’s contention that a medical device manufacturer had a duty to place a warning on the product itself “that third parties should not activate the PCA pump on behalf of the patient to whom it is prescribed.” Bard, Inc. , 3d 1272 (11th Cir.

Testimonials 59

Testimonials Licensing Licensing FDA 59

Drug & Device Law

NOVEMBER 9, 2023

357 (2002); United States v. That’s a significant step forward, since it aligns the FDA’s view of permissible science more closely to what doctors (and Medicare) actually rely on in clinical situations. E.g. , Sorrell v. IMS Health Inc. , 552 (2011); Thompson v. Western States Medical Center , 535 U.S. Caronia , 703 F.3d FDA , 119 F.

FDA 64

FDA Nurses Production Regulations 64