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The FDA has required that Pfizer place a black box warning on the label of its injectable contraceptive, Depo-Provera, which warns of potentially irreversible bone loss in women who use the product for more than two years.
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.
Pfizer will amend the labeling on its injectable contraceptive, Depo-Provera, to include a black box warning for potentially irreversible bone loss in women who use the product for more than two years.
Pharmaceutical companies Pfizer and Mallinckrodt have been issued untitled letters from the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) for infractions related to promotional materials for their products.
The FDA will soon issue a prescription drug labeling rule that will significantly change the way drugmakers advertise their products to consumers, as well as make patient package information more user-friendly, according to the agency’s acting commissioner.
The future of the FDA’s Critical Path Initiative — which aims to expedite the drug development process and bring more products to market — does not depend on who becomes the FDA commissioner next year, according a top agency official.
The FDA hopes a draft guidance for designing and conducting pharmacokinetic (PK) studies in pregnant women will stimulate R&D of appropriate treatments for such patients.
Pharmaceutical or device manufacturers seeking FDA approval for combination products may be eligible to reduce or waive agency user fees when they submit more than one application, according to a draft guidance from the agency.