FDA is permitting food and supplement firms to make nutrient content claims for products that contain the following omega-3 fatty acids: EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid) and ALA (alpha-linolenic acid).

With budget bills proposing caps on Medicare and Medicaid spending expected to reach the House floor next week, providers are lining up against them and hoping the House leadership will not support them.

A leading stalwart of last year’s $20 billion federal relief package for the states is blasting a General Accounting Office (GAO) report that suggests the money did not effectively stimulate the economy or relieve budget-weary states.

Mississippi consumer advocates and state lawmakers are battling to prevent 65,000 impoverished seniors and disabled people from losing their Medicaid coverage under a cost-cutting exercise Mississippi’s governor says is needed to reduce the state’s financial obligations under the new Medicare drug benefit.

A new General Accounting Office report showing few problems with Canadian Internet pharmacies is not statistically significant because GAO considered too few pharmacies, FDA argues.

The American Herbal Products Association (AHPA) now supports changing the law to require firms to report serious adverse events associated with dietary supplements so long as patient privacy and other data protections are ensured.

SAN FRANCISCO -- FDA intends to issue a long-awaited good tissue practices regulation soon and is forming a tissue safety team to oversee the final rule’s implementation, according to FDA biologics center chief Jesse Goodman.

The generic drug industry is urging FDA to alter a rule that allows brand-name drug firms to make certain labeling changes without FDA pre-approval as a way to block authorized generic drugs, which are drugs made by a brand-name firm and sold by a generic drug firm that is not eligible for 180-day exclusivity.

Organized labor officials fear a highly expected move by OSHA to delay enforcement of the respiratory protection standard could give industry groups time to convince lawmakers to write legislation removing tuberculosis protections from the regulation.

Medical professionals lobbying for expanded Medicare coverage of positron emission topography (PET) are welcoming CMS’ decision to let Medicare pick up the bill for PET scans on certain beneficiaries with suspected Alzheimer’s disease.

FDA plans to conduct a comprehensive review of its bioresearch monitoring program (BIMO) starting either late this year or early next year, according to a key FDA official.

A new report by the Medicare Payment Advisory Commission (MedPAC) holds open the possibility that the panel will back stringent new rules restricting admissions to long-term care hospitals (LTCHs) located within larger acute care hospitals, even as it proposes new criteria that would define the level of care provided by LTCHs.

The flagship proposal of the Bush administration’s initiative to help more institutionalized disabled Medicaid beneficiaries live at home or in their communities has, after almost 18 months, found a legislative vehicle and is expected to be voted on in the House next week, but cuts to Medicaid to fund the bill have generated new controversy.

SAN FRANCISCO -- FDA is planning a workshop with experts and industry this fall to discuss what animal models are appropriate to test the plague vaccine, FDA biologics center official William Egan told attendees of the Biotechnology Industry Organization’s June 7-9 annual conference.

FDA will establish an office of critical path opportunities as part of its initiative to make it easier for companies to move products from preclinical development down the “critical path” to market, according to FDA Acting Commissioner Lester Crawford.

Despite stiff resistance from Republican leaders, a House Appropriations subcommittee late Monday (June 14) voted to prevent FDA from spending any money in fiscal year 2005 to enforce the current ban on drug reimportation.

Republican-sponsored legislation designed to more tightly define OSHA’s controversial multi-employer citation policy and slow down the agency’s use of repeat citations will soon be introduced in the House, according to a congressional source.

FDA will announce the progress it has made with its initiative to overhaul good manufacturing practices and quality systems the day after Labor Day, according to FDA Acting Commissioner Lester Crawford.

CMS Administrator Mark McClellan is looking to create an office of patient advocacy at CMS that could serve as a venue for patient advocacy groups to weigh in on coverage and other policy issues.

A House corporate-tax bill that includes a multi-billion-dollar tobacco-farmer buyout could reinvigorate efforts by tobacco-control proponents to give FDA power to regulate tobacco.