FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Performance Review Board Members Announced

[ Price : $8.95]

Federal Register notice: FDA announces the names of the members who will serve on its fiscal year 2020 Performance Review Board.

ICH eCTD Document Q&A at Step 4

[ Price : $8.95]

The International Council on Harmonization says its electronic Common Technical Document question-and-answer document has reached ...

FDA Authorizes 1st Covid DTC Test

[ Price : $8.95]

FDA authorizes the first non-prescription DTC Covid-19 test kit.

FDA/Industry PDUFA 7 Discussions Updated

[ Price : $8.95]

FDA releases summaries from two PDUFA 7 reauthorization negotiation meetings.

AvKare Recalls Sildenafil, Trazodone Due to Mix-up

[ Price : $8.95]

AvKare (Pulaski, TN) withdraws one lot of sildenafil 100 mg tablets and one lot of trazodone 100mg tablets due to a product mix-up...

Torrent Pharma Recalls Anagrelide Due to Dissolution

[ Price : $8.95]

Torrent Pharmaceuticals recalls one lot of anagrelide capsules due to a dissolution test failure detected during routine quality t...

FDA Supports Oblato DIPG Treatment Trial

[ Price : $8.95]

Oblato says FDA has given positive detailed responses on plans for a Phase 1/2 trial of a new treatment for a rare pediatric cance...

False, Misleading Claims in Xatmep Professional E-Mail: OPDP

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion notifies Azurity about violations in a healthcare professional e-mail for the companys...

Panel Backs Pfizer Covid-19 Vaccine

[ Price : $8.95]

FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend an Emergency Use Authorization for Pfizer-BioN...

FDA Expands Partnership with Palantir Technologies

[ Price : $8.95]

FDA expands its partnership with Palantir Technologies through a new $44.4 million three-year contract.