The Bush administration may include a “sheathed needle” provision in its smallpox vaccination compensation plan, but it likely will not include a liability indemnification provision for companies manufacturing biodefense products, according to a high-ranking federal health official.

FDA's centers this March will begin reviewing all drug good manufacturing practices (GMP) warning letters, instead of allowing the field to send the letters directly to FDA's general counsel.

Informal talks of World Trade Organization ministers aimed at brokering a deal on access to medicines failed to find a solution, even as the United States tried to show new flexibility by signaling it is willing to accept an open-ended scope of diseases if only African countries are eligible to import generic medicines.

The omnibus appropriations bill signed by President Bush Feb. 20 provides FDA with its requested funding levels for countering terrorism and curbing medical errors, and gives the agency more than it had sought for generic drugs.

FDA's device center will not be collecting user fees for modular premarket applications (PMAs) if companies submitted the first module before Oct. 1, 2002, according to a draft guidance explaining how FDA will collect device user fees.

Rep. Bernie Sanders (I-VT) announced on Tuesday (Feb. 18) he has introduced legislation that would slap fines on drug manufacturers who refuse to provide drugs to Canadian wholesalers that sell to U.S. citizens.

A bipartisan group of House lawmakers is mounting a campaign to delay implementation of a looming CMS standard designed to crack down on inappropriate Medicare hospital outlier payments.

Congress has stripped a provision from the homeland security law that protects thimerosal producers -- most notably Eli Lilly -- from class-action lawsuits involving the vaccine preservative, while promising to enact a similar provision later this session as part of broader vaccine legislation.

FDA Feb. 20 unveiled several initial steps it is taking to implement a broad-sweeping plan to reform the pharmaceutical good manufacturing practices (GMP) program.

In another attack on the state's ergonomics standard, the Washington Senate this week passed with bipartisan support a measure that would make the regulation voluntary.

FDA will not enforce key elements of its electronic submission and recordkeeping rule as it weighs whether to revise the so-called “Part 11” regulations to facilitate innovation for modern manufacturing, electronic record keeping, and regulatory submissions.

FDA's drug center, veterinary drug center and Office of Regulatory Affairs (ORA) are setting up a centralized pharmaceutical inspectorate comprised of a specialized team of experts in drug product manufacturing that will conduct inspections of high-risk firms.

The recent introduction of a compromise cloning bill by key senators has significantly decreased the possibility the Senate will pass Sen. Sam Brownback's (R-KS) anti-cloning bill.

OSHA says the closing of a Maine agency office is only temporary after state lawmakers and members of the Maine's congressional delegation strongly objected to a potential move to consolidate the state's local offices.

The Small Business Administration's (SBA) regulatory watchdog branch has prioritized CMS' one-hour restriction on the use of patient restraints in hospitals for regulatory reform in a bid to reduce the burden on small businesses.

Two key Senate Democrats are attacking an American Bar Association (ABA) plan that is backed by industry and would establish medical criteria for asbestos plaintiffs, a proposal that is the crux of a new Republican bill to curb the spread of asbestos lawsuits.

Pediatric groups have failed to convince a federal appeals court to expedite a review of whether a district court erred in striking a controversial FDA rule that required biologics and drug firms to test their drugs on children.

The Senate health committee hopes to hold either a hearing or a markup later this month on legislation to reinstate FDA's pediatric rule that required manufacturers to conduct studies of drugs and biologics on children, according to a congressional and health advocacy group sources.

A biotechnology industry group is voicing its concerns with CMS' interim final rule on inherent reasonableness (IR), urging the agency to keep the IR process transparent and to use its authority to increase unjust payments rates, not just to reduce those that may be too high.

The U.S. government and its pharmaceutical industry are assessing a proposed WTO statement limiting the use of more flexible patent rules to see if it establishes legally binding limits that could inform a future dispute settlement panel, according to delegation and industry sources.