FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Emergency Use Authorizations Increase at FDA

[ Price : $8.95]

FDA and CDC tell the Institute of Medicine that Emergency Use Authorizations for approved and unapproved drugs has risen sharply i...

Vioxx Problems Known Long Before Withdrawal: Study

[ Price : $8.95]

Mount Sinai School of Medicine researchers say that previously unavailable clinical trials show concerns about Vioxx cardiovascula...

Pfizer Expects Tikosyn Shortage

[ Price : $8.95]

Pfizer gives healthcare professionals instructions for dealing with an anticipated shortage of 60-count bottles of Tikosyn 250 mcg...

FDA Debars Kane

[ Price : $8.95]

Federal Register Notice: FDA issues an order debarring Niaja Kane from providing services in any capacity to a person that has an ...

FDA OKs First Priority ANADA for Bacterial Infections

[ Price : $8.95]

Federal Register Final rule: FDA approves a First Priority ANADA for using sulfadimethoxine to treat bacterial infections in cattl...

Comments Sought on Reports of New Animal Drugs Experiences

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on recordkeeping and reports on experience with approved new animal drugs.

Guidance on Changes to Approved NADAs

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance for sponsors who wish to apply for approval of changes to approved new animal dru...

Advisors Back Expanded Spiriva Indication

[ Price : $8.95]

Members of FDAs Pulmonary-Allergy Drugs Advisory Committee say that trial data support Boehringer Ingelheims sNDA for an expanded ...

FDA Issues Revised ICH Q8 Parent Guidance

[ Price : $8.95]

FDA publishes a second revision of the ICH Q8 Pharmaceutical Development guidance.

FDA Approves Expanded Indication for Geodon

[ Price : $8.95]

FDA approves an expanded indication for Pfizers Geodon capsules for maintenance treatment of Bipolar I disorder as an adjunct to l...