Regulation and Compliance - BioPharm International

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Regulation and Compliance

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.

Biotech Drug Prices Under Scrutiny

February 1, 2009

With cuts in healthcare, biotech drugs are under scrutiny.

Serving Two Masters: Reconciling EMEA/GAMP 5 and FDA/cGMP Phase 1

January 1, 2009

QbD can help satisfy FDA and EMEA requirements.

Revitalization, Reform Ahead for The FDA

January 1, 2009

FDA aims to regain public confidence in 2009.

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