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The Center for Biologics Evaluation and Research (CBER) issued a guidance manual Dec. 1 formalizing a systems-based approach to conducting inspections at source plasma establishments.
The FDA published a final guidance Nov. 29 outlining recommendations on the use of symbols on labeling for in vitro diagnostic devices (IVDs) to harmonize standards of conveying pertinent and required information about the devices.
Manufacturers wanting to challenge medical device user fees should pursue an internal review with the FDA instead of seeking more formal dispute resolution alternatives, such as filing a citizen petition or requesting an evidentiary hearing, according to a newly released FDA guidance document.
The FDA's Center for Biologics Evaluation and Research (CBER) has released a guidance manual that formalizes a systems-based approach to conducting inspections at source plasma establishments.
A FDA compliance policy guidance aims to assist pharmaceutical firms implement radio-frequency identification (RFID) feasibility studies and pilot programs, which in turn will strengthen the U.S. drug supply chain and to promote the widespread use of RFID technology by 2007.
The FDA will not take enforcement action against firms that submit, via annual report, postapproval manufacturing changes made to comply with an official compendium, the agency said.
Drugmakers that submit, via an annual report, postapproval manufacturing changes made to comply with an official compendium will not face FDA enforcement action, the agency announced in a guidance document.
The FDA will not take action against firms that submit, via annual report, postapproval manufacturing changes made to comply with an official compendium, the agency announced in a guidance document.
The expected prescription drug labeling rule from the FDA will make patient package information more user-friendly and change the way drugmakers advertise their products to consumers, according to the agency’s acting commissioner.
A new FDA compliance policy guidance aims to promote the widespread use of radio-frequency identification (RFID) technology by 2007 by assisting drugmakers with the implementation of RFID feasibility studies and pilot programs.