FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guidance on IRB Responsibilities

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance, IRB Responsibilities for Reviewing the Qualifications of Investigators, Ad...

Guidance on Anticoccidial Drugs In Food-Producing Animals

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance, Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals.

ICH Guidance on Q11 Development/Manufacture of Drug Substances

[ Price : $8.95]

Federal Register Notice: FDA releases an ICH guidance, Q11 Development and Manufacture of Drug Substances.

FDA Posts Therapeutic Data Standards

[ Price : $8.95]

Federal Register Notice: FDA posts on its Web site a roadmap of its current thinking on therapeutic priority area data standards f...

FDA Clears TomTec Imaging Software

[ Price : $8.95]

FDA clears a TomTec Imaging Systems 510(k) for its new Image-Com 5 software solution.

House Committee Seeks FDA Timelines on NECC Actions

[ Price : $8.95]

House Energy and Commerce Republican leaders ask FDA commissioner Margaret Hamburg for timelines and internal communications relat...

Public Citizen Calls for Probe on CMS Role in Compounding

[ Price : $8.95]

Public Citizens Health Research Group has called for an HHS Inspector General investigation into whether financial incentives crea...

HeartSine Class 1 Recall on Samaritan Defibrillators

[ Price : $8.95]

HeartSine begins a Class 1 recall involving certain Samaritan 300/300P Public Access Defibrillators after determining they may i...

FDA Approves Expanded Use for Glaxos Promacta

[ Price : $8.95]

FDA approves GlaxoSmithKlines Promacta for treating thrombocytopenia in patients with chronic hepatitis C.

FDA Amends Dates on Device ID System Rule

[ Price : $8.95]

Federal Register Notice: FDA amends its 7/10 proposed rule on a unique device identification system to change the proposed effecti...