Regulation and Compliance - BioPharm International

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Regulation and Compliance

Health Reform Challenges Biotech Industry

August 1, 2009

Pressures to reduce healthcare spending generates proposals to spur competition, cut costs.

How to Shift from Reactive Compliance to Strategic Quality Management

July 1, 2009

A culture of quality that emphasizes business objectives, risk management, and the informed application of technology can improve compliance.

Extended Risk Management Proposals Challenge Manufacturers

July 1, 2009

The FDA seeks new strategies for improving the safe use of opioids and other high-risk medicines, including erythropoiesis stimulating agents.

Stiffer Enforcement at the FDA

June 1, 2009

Agency officials promise swift action against violators of drug safety and quality regulations.

On the Horizon: New Expression Systems to Become Common Industry Platforms

June 1, 2009

New expression systems compete for attention.

Comparative Effectiveness Research to Shape Biotech Studies

May 1, 2009

Authorities are pushing for CE; manufacturers prefer to focus on value.

When Less is More: Lean Can Help Reduce Costs and Improve Compliance Simultaneously

May 1, 2009

Use Lean techniques to improve manufacturing compliance

Food and Drug Safety Crises Prompt White House, Congressional Action

April 1, 2009

The FDA is poised to gain more authority and resources to ensure product quality.

Biotech Therapies Face Disclosure Requirements

March 1, 2009

Broader transparency in product prices and payments to researchers aim to curb conflicts of interest and rationalize drug expenditures.

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