Abbott Molecular’s Des Plaines, Ill., facility received six observations related to its hepatitis B virus (HBV) in vitro diagnostic. Read More

From calls for consistency and clarity to demands to end its unofficial “corrective fix” recall program, CDRH has received a docket full of suggestions on how to integrate new science into its regulatory policies. Read More

A new disclosure rule, part of a broad effort under the American Recovery and Reinvestment Act to expand privacy and security relating to personal electronic health records (EHRs), went into full force this month, requiring most research sites to report unauthorized acquisition, access, use or disclosure of personal health information. Read More

The FDA has asked the Orthopedic and Rehabilitation Devices Panel to reconsider the 510(k) clearance of ReGen Biologics’ Menaflex collagen scaffold March 23.  Read More

Cardiac Science is providing customers with a new software update after the FDA told the company in a Feb. 5 warning letter that its previous update would not prevent failures of its Powerheart automated external defibrillators. Read More

Citing a lack of statistics from CDRH, an Institute of Medicine (IOM) committee charged with reviewing the 510(k) process is turning to data from devicemakers and other healthcare groups to fill in the gaps. Read More

Plaintiffs in a class action antitrust lawsuit against Pfizer are asking the U.S. District Court for the District of New Jersey to review company documents, saying they may show the drugmaker wrongfully tried to delay generic competition for its epilepsy drug Neurontin. Read More

The FDA and the European Medicines Agency (EMA) will allow sponsors to send a copy of the same orphan drug designation annual report to each agency.  Read More

FDA Commissioner Margaret Hamburg told a Senate appropriations subcommittee Tuesday that an increase of $101 million in funding — $51 million of which would come from two new user fees — is needed to finance the agency’s Protecting Patients Initiative. Read More

The FDA has warned Xian Libang Pharmaceutical, a maker of active pharmaceutical ingredients (APIs), because its quality control unit failed to detect that an employee had manipulated testing data on incoming raw materials. Read More

The FDA will test a new standardized template to quickly and clearly communicate risk to consumers during the next big recall. Read More