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Beginning at the end of the month, the FDA will require drugmakers to adopt the structured product language (SPL) format for certain human drug labeling submissions, according to an agency official.
The FDA has signed five-year cooperative research contracts with four organizations through which the agency will continue to conduct postmarketing research via several massive patient databases.
Manufacturers, distributors and retailers in multiple industries, along with technology developers and providers, are abuzz over the potential for radio-frequency identification (RFID) to secure the supply chain and prevent counterfeiting, theft and diversion.
The FDA has released a draft guidance that encourages industry to electronically distribute important product information, such as that included in recalls and drug safety announcements, and it explains procedures for doing so based on regulations governing the paper circulation of such information.
Breast implant manufacturer MediCor is positioning itself to enter the silicone breast implant market, noting it has been encouraged by recent FDA approvable letters issued to other firms for their silicone gel-filled breast implants.
Devicemaker Kensey Nash has submitted an investigational device exemption application to the FDA seeking approval to study a new version of its TriActiv Embolic Protection System platform for use during carotid stenting procedures.
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has launched an Internet search portal that provides a centralized location to access clinical trial registries and databases worldwide.
The FDA is unlikely to complete its long-awaited revision of 21 CFR Part 11 — which regulates the use of electronic records and signatures — by the end of the year as industry observers had expected, an agency official said this month.
The FDA recently approved a wireless medical monitoring device developed by Guidant that the company says will allow doctors to more easily assess their patients' health histories and pass that information on to other physicians.
Due to concerns over its methodology and timeliness, both industry officials and patient advocates are questioning how much influence a recent study of implantable cardioverter defibrillators (ICDs) should have in setting FDA policy.