FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Generic Biologics Still an Open Issue in Health Reform

[ Price : $8.95]

House and Senate health reform bill both support 12 years market exclusivity for branded biologics facing generic competition, but...

Burzynski IRB Violations Cited

[ Price : $8.95]

FDA warns Burzynski Research Institute IRB about multiple violations of laws and regulations intended to protect human subjects.

Grassley Asks 31 Health Organizations for Industry Funding Info

[ Price : $8.95]

Sen. Charles Grassley asks 31 health and medical professional organizations for detailed information on their funding from drug an...

FDA Orphan Status for Stem Cell Therapy

[ Price : $8.95]

FDA grants California Stem Cell, Inc. an orphan drug designation for Motorgraft, a stem cell-derived motor neuron product for trea...

Panel to Discuss Cymbalta For Chronic Pain

[ Price : $8.95]

Federal Register Notice: FDAs Anesthetic and Life Support Drugs Advisory Committee will meet 1/28/10 to discuss safety and efficac...

Oncologic Drugs Panel Notice Amended

[ Price : $8.95]

Federal Register Notice: FDA amends the notice of the 12/16 Oncologic Drugs Advisory Committee meeting to reflect the cancellation...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites Aluwe, Burzynski Research Institute IRB, Chi Machine, Icon Clinical Research, PM...

FDA Publishes Patient-report Outcomes Guidance

[ Price : $8.95]

FDA issues a guidance explaining how it reviews and evaluates patient-reported outcome instruments used to support medical product...

FDA Staff Concerned About Cayston Trials

[ Price : $8.95]

FDA tells the Anti-infective Drugs Advisory Committee that there are staff concerns about the clinical trials submitted to support...

Dey Wants FDA Restrictions on Generic EpiPens

[ Price : $8.95]

Dey Pharma petitions FDA not to approve generic EpiPen ANDAs unless they have exactly the same design, operation, and function, in...