Policy makers weigh new rules to ensure the safety and quality of nanomaterials in biomedical products.
Nov 1, 2008
By:
Jill Wechsler
The FDA and other regulatory authorities are evaluating new regulations to ensure the safety and quality of nanomaterials in biomedical products.
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New pilot supports manufacturers that establish quality systems to manage product risk.
Oct 1, 2008
By:
Jill Wechsler
The FDA's QbD pilot program is supporting good manufacturing on a global basis.
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The FDA is increasing foreign inspections and adopting new initiatives to ensure the quality of imported medicines.
Sep 1, 2008
By:
Jill Wechsler
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.
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Expanded access to healthcare data will modernize drug-safety assessment and product development.
Aug 1, 2008
By:
Jill Wechsler
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.
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Physician pay-patch bill offers something for everyone without resolving reimbursement problems.
Jul 18, 2008
By:
Jill Wechsler
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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Economic incentives and regulatory flexibility can spur development of treatments for small patient populations.
Jul 1, 2008
By:
Jill Wechsler
The US Food and Drugs Administration is boosting its efforts for orphan drugs development.
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Biotech companies fear comparative effectiveness analysis will emphasize product costs over value.
Jun 1, 2008
By:
Jill Wechsler
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.
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Under fire, FDA is taking steps to regain its stature as an effective science-based regulatory agency.
May 1, 2008
By:
Jill Wechsler
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.
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The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight
Apr 1, 2008
By:
Jill Wechsler
The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight.
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