Menu
View Cart  

Recommended Products

Visit Store
Gmp-inspection-preparation-checklist-130x160

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological-risk-eval-and-mngmnt-for-md-130x160

Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Events

View All
Oct 17

Quality Metrics Redux: Taking Advantage of FDA’s Renewed Focus

Oct 18

Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)

Oct 18

The CDER Reorganization: What It Means for Drugmakers

Oct 23

13th Annual FDA Inspections Summit

Oct 30

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Oct 30

Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

Editor's Picks

View all
Redwarningstamp

FDA Warns Becton Dickinson for Potentially Contaminated Water, Environmental Conditions

The company promised to discontinue use of tap water.
Fda_logo_black_2016

FDA Releases 25 Product-Specific Guidances for Generics

“In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections,” said FDA Commissioner Scott Gottlieb.

IMPROVED VERSION OF KALETRA CLOSER TO USE IN EUROPE

KEYWORDS Drug Pipeline Alert
A A

The European Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending approval for a new tablet formulation of Abbott's Kaletra (lopinavir/ritonavir).

The company said it expects a decision on marketing approval for Kaletra, a protease inhibitor used in the treatment of people with HIV, from the European Commission (EC) within 90 days.

The new tablet formulation is intended to be more convenient than the capsule currently available. It requires fewer doses per day, does not need to be refrigerated and can be taken with or without food.