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A breakdown of the FDA’s proposed budget for fiscal 2005, which represents an increase of $149 billion over last year’s appropriations, reveals that the agency wants to tap into industry user fees, rather than congressionally approved funding, to pay for most of its new full-time employees.
Devicemakers that act as sponsors during clinical trials need to be careful that the investigators selected to conduct the trials have appropriate training and experience to use the device being tested.
The FDA for the first time has issued draft guidance to help steer devicemakers through risk information disclosure requirements for direct-to-consumer (DTC) ads for hearing aids, contact lenses and other restricted devices.
The FDA and the Securities and Exchange Commission (SEC) have announced new measures for uncovering false and misleading statements by device manufacturers and other FDA-regulated companies, including establishing a blanket authorization for some staff to share confidential information.
Various neonatal chemistry systems and Immunoisoelectric focusing diagnostic kits manufactured by PerkinElmer Life Sciences were seized last week after the FDA repeatedly warned the company to correct numerous quality system violations at its Norton, Ohio facility where the products are manufactured.
The appropriations slump that threatened to end the device user fee program will be made up next fiscal year under President Bush’s latest budget proposal, which will allow the Center for Devices and Radiological Health (CDRH) to continue assessing fees until Oct. 1, 2007.
The FDA has released a new supplement to the Orange Book list of “Approved Drug Products With Therapeutic Equivalence Evaluations,” a compendium that lists prescription drug products with therapeutic equivalence evaluations; over-the-counter drug products that require approved applications as a condition of marketing; approved drug products administered by the Center for Biologics Evaluation and Research; and products that have never been marketed, are for export, have been discontinued from marketing or that have had their approvals withdrawn for reasons other than safety or efficacy.
Beginning next year, drug companies will have to alter the way they submit changes to drug labeling, switching from portable document format (PDF) to the structured product labeling (SPL) format in order to meet electronic prescribing and health record mandates in the Medicare prescription drug law, the FDA said last week.
HHS Secretary Tommy Thompson must turn over all cost estimates associated with the new prescription drug benefit added to the Medicare program by Feb. 17, House Democratic leaders demanded last week.
The FDA should include guidelines on the conditions and types of studies or study designs that would warrant DNA/RNA collection as part of its pharmacogenomics draft guidance, Johnson & Johnson (J&J) said in recent comments.