Regulatory Beat - BioPharm International

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Regulatory Beat

FDA Leaders Stress Science and Compliance

October 1, 2009

Stiffer enforcement of quality standards aims to restore public confidence in agency actions.

Biopharmaceutical Manufacturers Seize Opportunities in the Global Health Arena

September 1, 2009

The FDA is encouraging manufacturers to invest in research and development for new vaccines and therapeutics to combat third-world diseases.

Health Reform Challenges Biotech Industry

August 1, 2009

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

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.

Comparative Effectiveness Research to Shape Biotech Studies

May 1, 2009

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

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.

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