FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Ex-FDA Chief of Staff Joins DC Law Firm

[ Price : $8.95]

Former FDA chief of staff and deputy chief counsel Denise Esposito joins Covington & Burling as a partner and co-chair of its food...

China API Inspection Passes with No 483 Citations

[ Price : $8.95]

FDA inspects a ScinoPharm drug manufacturing facility located in the Changshu Economic Development Zone in Jiangsu Province, China...

FDA Clears EDAP Ablatherm HIFU for Prostate Tissue

[ Price : $8.95]

FDA clears an EDAP TMS 510(k) to market its Ablatherm Integrated Imaging HIFU (High intensity focused ultrasound) for ablating pro...

CDER Policy on ANDA Amendment Filing Reviews

[ Price : $8.95]

CDER posts a policy document on the Review of ANDA Amendments and Supplements by the Division of Filing Review.

Dr. Reddys Needs Third-party Auditor, CEO Says

[ Price : $8.95]

Dr. Reddys Laboratories says FDA has directed it to hire a third-party auditor to evaluate its three Indian manufacturing plants t...

FDA Hits LDT Firms for DTC Tests Without Clearance

[ Price : $8.95]

FDA sends three laboratory-developed test makers letters challenging their genetic tests being marketed to consumers without agenc...

FDA Breakthrough Status for Tevas SD-809

[ Price : $8.95]

FDA grants Teva Pharmaceutical Industries a breakthrough therapy designation for SD-809 (deutetrabenazine) for treating patients w...

FDA Grants Collegium Tentative Approval on Pain Drug

[ Price : $8.95]

FDA grants Collegium Pharmaceutical tentative approval for its NDA for Xtampza ER (oxycodone) extended-release capsules for managi...

Purdue Petition Seeking Delay on Pfizer Pain Drug Denied

[ Price : $8.95]

FDA denies without comment a petition from Purdue Pharma that sought an order from FDA to require a Pfizer 505(b)(2) NDA for pain ...

FDA Rare Pediatric Disease Status for ArmaGen Drug

[ Price : $8.95]

FDA grants ArmaGen a rare pediatric disease designation for AGT-181, a potential treatment for patients with Hurler syndrome.