FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

How IPRs Relate to Waxman-Hatch Stays

[ Price : $8.95]

Attorney Brian Coggio describes the impact of an inter partes review on an FDA 30-month stay of a generic drug ANDA during patent ...

FDA Seeks Device Development Tools Pilot Participants

[ Price : $8.95]

FDA looks for nominations for participants in a voluntary Medical Device Development Tools pilot program intended to improve the d...

Fraudulent Ebola Treatments Online: FDA

[ Price : $8.95]

FDA says consumers should be aware that despite Internet claims to the contrary, there are no approved vaccines or drugs for Ebola...

Guidance on Drug/Biologic Clinical Pharmacology Labeling

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Clinical Pharmacology Labeling for Human Prescription Drug and Biological ...

Guidance on Device De Novo Classification

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance for medical devices: De Novo Classification Process (Evaluation of Automati...

Comments Reopened on Drug Naming Practices

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period for a draft guidance on best practices in developing proprietary names for...

Workshop on Preventing Staphylococcus aureus

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 9/5 on the clinical development of drugs for preventing serious infections ca...

FDA Corrects Rule on Drug/Biologic Safety Reports

[ Price : $8.95]

Federal Register Notice: FDA corrects a 6/10 final rule on postmarketing safety reports for human drug and biological products.

Public Citizen Cautions on Mercks New Sleep Drug

[ Price : $8.95]

Public Citizen says FDAs decision to approve Mercks Belsomra (suvorexant) will surely worsen the public health crisis caused by th...

Amgen Reports Disappointing Kyprolis Trial Results

[ Price : $8.95]

Amgen says a Phase 3 clinical trial called FOCUS involving Kyprolis (carfilzomib) did not meet its primary endpoint of improving o...