FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CDER Revises ANDA Impurities Guidance

[ Price : $8.95]

FDA releases an updated guidance document that provides recommendations on the chemistry, manufacturing, and controls information ...

FDA Says McNeil Quality Problems Continue

[ Price : $8.95]

An FDA inspection finds continuing and repeat quality violations at a McNeil Puerto Rico manufacturing facility.

FDA Issues 2 Bacterial-Product Guidances

[ Price : $8.95]

FDA issues two guidances on aspects of antibacterial drugs.

FDA Could Have Done Better for Staff Training at OPM

[ Price : $8.95]

Consulting editor John Scharmann compares expensive outsourced FDA staff training programs with low-cost comparable programs at th...

Animal Drug Sponsor Changed to Belcher Pharmaceuticals

[ Price : $8.95]

Federal Register Final rule: FDA changes an animal drug sponsor name in the regulations to Belcher Pharmaceuticals LLC.

Comments Sought on Type A Medicated Articles

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on recordkeeping requirements for Type A medicated article manufacturers.

List of Approved PMAs Published

[ Price : $8.95]

Federal Register Notice: FDA publishes a list of approved PMAs to inform the public of the availability of safety and effectivenes...

Blood Products Panel to Meet

[ Price : $8.95]

Federal Register Notice: FDAs Blood Products Advisory Committee will meet 12/14-15 to discuss dengue virus infection, murine leuke...

Comments Sought on Animal Drug User Fee Form

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on the Animal Drug User Fee Act Cover Sheet.

Comments Sought on Medicated Feed CGMP

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on CGMPs for medicated feeds.