FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CDER Deputy Throckmorton Retiring in January

[ Price : $8.95]

CDER deputy director for regulatory programs Doug Throckmorton announces his retirement after 27 years at the agency.

FDA Revokes EUAs on Covid Tests

[ Price : $8.95]

Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Cue Health for the Cue Covid19 Test, and Cue Covid...

FDA Provides More Draft ANDA-Specific Guidances

[ Price : $8.95]

Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug sponso...

Fludarabine Phosphate Labeling Changes OKd

[ Price : $8.95]

FDA announces approved labeling changes for Sandoz fludarabine phosphate injection under the Oncology Center of Excellences Projec...

FDA Clears Ultromics EchoGo Amyloidosis Device

[ Price : $8.95]

FDA clears an Ultromics 510(k) for the EchoGo Amyloidosis for detecting cardiac amyloidosis.

Sage Ending Dalzanemdor Development

[ Price : $8.95]

Sage says it is ending dalzanemdor development in Huntingtons disease cognitive impairment following Phase 2 DIMENSION results tha...

FDA Finds CGMP Violations in Originitalia Inspection

[ Price : $8.95]

FDA warns Italys Originitalia about CGMP violations in its production of finished drugs.

Put Semaglutide Drugs on DDC Lists: Novo Nordisk

[ Price : $8.95]

Novo Nordisk petitions FDA to take specific steps to follow through on the companys nomination of semaglutide (Rybelsus, Ozempic, ...

CGMP Violations at Silliker Contract Lab

[ Price : $8.95]

FDA cautions Silliker contract testing laboratory about CGMP violations at its Gainesville, FL, facility.

Toms of Maine CGMP Issues

[ Price : $8.95]

FDA warns the Colgate-Palmolive Toms of Maine unit about CGMP violations in its manufacturing of finished drugs.