[Washington Post /AP]  The Food and Drug Administration would collect hundreds of millions of dollars in new fees from pharmaceutical companies to help speed up the review of generic drugs, under an agreement with industry released by the agency on Friday.
The user fee proposal is one of three such agreements that the agency is submitting [...]

This past week both Merck and Teva Pharmaceutical Industries, Ltd. faced legal complications concerning select drug products. Merck received a subpoena from U.S. regulators regarding marketing techniques of three drugs: Temodar, PegIntron, and Intron A in addition to dealing with problems from the Enviornmental Protection Agency. Similarly, TEVA was sued by GlaxoSmithKline and Pfizer for [...]

(Reuters) – Drug companies that had medicines tested by contractor Cetero Research might have to reevaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples.
The Food and Drug Administration said on Tuesday two 2010 inspections, an internal company investigation and a third-party audit uncovered “significant instances of misconduct and violations” [...]

[WSJ]- The vast majority of U.S. hospitals have restricted the use of life-saving chemotherapy drugs and other critical-care medications in the past six months to cope with unprecedented shortages, according to a survey released Tuesday.
More than 80% of hospitals surveyed by the American Hospital Association reported they had to delay treatment, and nearly 70% [...]

[WSJ]- SILVER SPRING, Md.—Breast-cancer patients who say Roche Holding AG’s Avastin saved their lives opened an appeals hearing on the drug Tuesday, calling on the Food and Drug Administration to let the “miracle” medicine keep its approval.
The FDA, which has emphasized concerns about whether the drug works on breast cancer, took off the gloves Tuesday [...]

[LA Times]- A Food and Drug Administration advisory panel said Tuesday that genetic tests directly marketed to consumers should be allowed only under a doctor’s supervision.
Personal testing, which is mainly available online from firms operating outside traditional medical institutions, can produce ambiguous or misleading results without proper analysis, panel members said.
“I would suggest that we [...]

[Bloomberg]- U.S. regulators plan to outsource more inspections of overseas factories within the next decade after criticism from Congress about a lack of oversight for food and drugs made in other countries.
The Food and Drug Administration aims to increase its reliance on third-party inspectors and has started reaching out to industry trade groups about the [...]

[HealthDay News] — A surprising number of valuable new drugs and vaccines approved in the United States have arisen wholly from research funded by the public sector, new research finds.
The authors of a study published Feb. 10 in the New England Journal of Medicine count 153 new drugs and vaccines from public sector research institutes [...]

[FDA]Today the U.S. Food and Drug Administration proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more [...]

[Boston.com] Top executives of the state’s two largest biotechnology companies offered diverging views today on the health care bill signed into law by President Obama, with one contending it protects innovation and the other insisting it does little to control costs. “I don’t think this health care reform really addresses the fundamental underlying issues that [...]