FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

sGERD Drug Development Guidance

[ Price : $8.95]

FDA publishes a guidance to help sponsors with clinical trials for drugs to treat symptomatic nonerosive gastroesophageal reflux d...

J&J Reports Positive Data in Psoriasis Drug

[ Price : $8.95]

Johnson & Johnson reports favorable data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies that showed its experimental psoriasis dr...

Exactech Pays $8 Million in Whistleblower Cases

[ Price : $8.95]

The Justice Department says Gainesville, FL-based Exactech is paying $8 million to resolve four whistleblowers allegations that th...

Are FDA Advisory Committees Doomed?

[ Price : $8.95]

FDA Matters founder Steven Grossman speculates on why FDA commissioner Martin Makary may want to limit or eliminate the role of ad...

AstraZeneca Fasenra Trial Misses in COPD

[ Price : $8.95]

AstraZeneca reports that data from a Phase 3 trial of Fasenra (benralizumab) did not achieve the primary endpoint in patients with...

4 Observations in Lupin Inspection

[ Price : $8.95]

FDA releases the form FDA-483 with four observations from an inspection at the Lupin drug manufacturing facility in Madhya Pradesh...

Becton Dickinson Expands Alaris Pump Recall

[ Price : $8.95]

Becton Dickinson expands its Class 1 recall of its Alaris Pump Module model 8100 to include 15 additional infusion sets, citing po...

FDA DTC Push Cites GLP-1 Drugs in 4 Letters

[ Price : $8.95]

FDAs ongoing crack down on drug direct-to-consumer promotional activities results in three just-released Warning Letters to Eli Li...

Concerning DTC Ad Misbrands Hizentra: FDA

[ Price : $8.95]

FDA warns CSL Behring that a direct-to-consumer TV spot for its Hizentra overstates the drugs effectiveness and minimizes its risk...

Multiple Violations in Illegal Marketing of SeniorLife.AI

[ Price : $8.95]

FDA warns Bellevue, WA-based SeniorLife.AI about multiple violations in its illegal marketing of an artificial intelligence-based ...