Articles by Jill Wechsler - BioPharm International



Articles by Jill Wechsler

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.

Biotech Innovation Boosts Orphan Drug Development

Economic incentives and regulatory flexibility can spur development of treatments for small patient populations.
Jul 1, 2008

The US Food and Drugs Administration is boosting its efforts for orphan drugs development.

Healthcare Reform Threatens Biotech Coverage and Access

Biotech companies fear comparative effectiveness analysis will emphasize product costs over value.
Jun 1, 2008

The comparative research approach may be preferable to price controls in the guise of government negotiations for the Medicare drug benefit, coverage denials, and limits on access to new technologies.

An Underfunded FDA Fights Back

Under fire, FDA is taking steps to regain its stature as an effective science-based regulatory agency.
May 1, 2008

The FDA is under attack from all sides. Many influential members of Congress either don't trust the agency to monitor the industry appropriately, or have found it politically expedient to keep sounding alarms about inadequate oversight of food and drug safety and clinical research. The good news is that there seems to be a growing consensus that FDA needs a major infusion of cash to regain its stature as an effective science-based regulatory agency.

FDA's Inspection Program Under Scrutiny

The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight
Apr 1, 2008

The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight.

CDER Gains Woodcock as Permanent Chief

Mar 12, 2008

When CDER director Steven Galson left last year, Janet Woodcock shifted back as temporary chief. And now, after a long search for a replacement, she has decided to take on the job herself.



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