Primavera Nueva Inc. Issues Voluntary Recall of Select 4-Count Tamales Because of Possible Health Risk- Revised to Include Roasted Pumpkin & White Cheddar, a Seasonal Item

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/24/2020
Short Title (70 char) Bruce G. Rankin, DO. DeLand, FL. EIR issued 11/24/2020
FEI Number 3006528394
Firm Name Bruce G. Rankin, DO
Record Type EIR
State FL
Establishment Type Clinical Investigations

This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product.

C3TI aims to increase experience in Bayesian statistical methods in simple trial settings across sponsors, CDER clinical reviewers, and CDER statisticians, including deepening an understanding of their applicability, opportunities, and challenges.

CGMP/Finished Pharmaceuticals/Adulterated

Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer level. FDA analysis found the p

Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet