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PerkinElmer Life Sciences has reached an agreement with the FDA that will allow it to resume producing and shipping various neonatal chemistry systems and immunoisoelectric focusing diagnostic kits.
President Bush has selected FDA Commissioner Mark McClellan to be the next administrator of HHS' Centers for Medicare & Medicaid Services (CMS), the White House announced Feb. 20.
The FDA has revised the voluntary (FDA 3500) and mandatory (FDA 3500A) MedWatch reporting forms to increase scrutiny of adverse events involving reprocessed single-use devices (SUDs).
Computers connected to the internet are the most problematic security threat to corporate data systems because users may be unknowingly downloading viruses and malicious codes to the network, according to Shimon Gruper, executive vice president of Internet Technology at Aladdin.
Utah Medical Products (UTMP) has filed a lawsuit against the FDA to prevent the agency from conducting wasteful inspections at its Medvale, Utah, manufacturing plant.
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The FDA for the first time has issued draft guidance to help steer devicemakers through risk information disclosure requirements for direct-to-consumer (DTC) ads for hearing aids, contact lenses and other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.