Articles by Jill Wechsler - BioPharm International

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Articles by Jill Wechsler

Revitalization, Reform Ahead for The FDA

FDA aims to regain public confidence in 2009.
Jan 1, 2009

FDA aims to regain public confidence in 2009.

Daschle to Spearhead Health Reform Efforts

Dec 10, 2008

Although no official announcement has been made, former Senate majority leader Tom Daschle is most likely slated to head the Obama administration’s efforts to enact health reform legislation as the new secretary of the Department of Health and Human Services.

Waxman to Head Hey House Committee

Dec 10, 2008

In the Obama administration, an important ally in the House for Tom Daschle, who is expected to be named secretary of the Department of Health and Human Services, will be Rep. Henry Waxman (D-CA), who unseated John Dingell (D-MI), the long-time top Democrat on the House Energy and Commerce Committee, to become the panel’s new chairman.

Big Changes Ahead for Biotech Manufacturers

To expand coverage amidst the economic crisis, Obama will be looking hard for ways to cut healthcare costs.
Dec 1, 2008

To expand coverage amidst the economic crisis, Obama will be looking hard for ways to cut healthcare costs.

Nanotechnology Creates Opportunities, Challenges for Biotech Manufacturers

Policy makers weigh new rules to ensure the safety and quality of nanomaterials in biomedical products.
Nov 1, 2008

The FDA and other regulatory authorities are evaluating new regulations to ensure the safety and quality of nanomaterials in biomedical products.

FDA Promotes QbD for Biotech Therapies

New pilot supports manufacturers that establish quality systems to manage product risk.
Oct 1, 2008

The FDA's QbD pilot program is supporting good manufacturing on a global basis.

Global Manufacturing Challenges Industry Regulators

The FDA is increasing foreign inspections and adopting new initiatives to ensure the quality of imported medicines.
Sep 1, 2008

The heparin debacle and other crises involving imported drugs and biologics has put pressure on the US FDA to step up its oversight of foreign drug manufacturing.

FDA Seeks Active System for Monitoring Adverse Events

Expanded access to healthcare data will modernize drug-safety assessment and product development.
Aug 1, 2008

The Sentinel System aims to generate more adverse event reporting by health professionals, to analyze health information more effectively, and to enhance FDA methods for communicating new safety information to providers and patients.

Medicare Drug Coverage Under Fire

Physician pay-patch bill offers something for everyone without resolving reimbursement problems.
Jul 18, 2008

Enough Republicans sided with Democrats last month to approve legislation canceling a scheduled 10.6% cut in Medicare fees for physicians. In doing so, the legislators tacked on dozens of provisions pleasing to beneficiaries and providers alike.

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