The Rare Diseases Program facilitates, supports and accelerates the development of drug and biologic products for the benefit of patients with rare disorders
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Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns
Extended Tip Applicator recall due to potential non-sterile product and high endotoxin levels. May cause inflammation or infection if used.Internet Pharmacy Warning Letters
Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA has issued warning letters informing the website operators that they are engaged in illegal activity in violation of the U.S. Federal Food, Drug, and Cosmetic ActFrank Steven Eder, MD. Binghamton, NY. EIR issued 11/23/2020
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/23/2020
Short Title (70 char) Frank Steven Eder, MD. Binghamton NY. EIR issued 11/23/2020
FEI Number 3006983127
Firm Name Frank Steven Eder, MD
Record Type EIR
State FL
Establishment Type Clinical InvestigatC3TI Demonstration Program Proposal Submission
Submitting content and format of the C3TI Demonstration Program ProposalConvenience Kit Recall: Medline Industries, LP, Removes Medline Neonatal and Pediatric Kits containing Smiths Medical ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation
Medline Neonatal and Pediatric convenience kits that include Smiths Medical ORAL/NASAL Endotracheal Tubes are used for intubation.Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication
Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolic