BENTONVILLE, Ark. — IBM, KPMG, Merck and Walmart announced Thursday that the companies have been selected by the United States Food and Drug Administration (FDA) to be included in a program in support of the U.S. Drug Supply Chain Security Act (DSCSA) that addresses requirements to identify, track and trace prescription medicines and vaccines distributed
WASHINGTON — Dr. Norman “Ned” Sharpless, director of the National Cancer Institute, will become acting commissioner of the Food and Drug Administration next month. Health and Human Services Secretary Alex Azar said Tuesday that Sharpless will take the reins of the FDA after the resignation of Scott Gottlieb. The administration is seeking a permanent replacement
SILVER SPRING, Md. — Food and Drug Administration Commissioner Scott Gottlieb is resigning, effective in about a month. The 46-year-old Gottlieb, who has been commuting weekly to the FDA office here from his home in Connecticut, wants to spend more time with his family, an administration official told The Washington Post. Health and Human Services
DEERFIELD, Ill. — Walgreens said Tuesday it welcomed the opportunity to meet with Food and Drug Administration commissioner Scott Gottlieb to discuss the steps it is taking to prevent the sale of tobacco products to minors. The retailer issued the statement after Gottlieb said the FDA had written to Walgreens “to request a meeting to
SILVER SPRING, Md. — FDA Commissioner Dr. Scott Gottlieb issued the following statement Friday on a new policy to improve access and foster price competition for drugs that face inadequate generic competition: “In too many cases, branded drugs that are no longer protected by patents or other exclusivities do not face expected competition. In fact,
WOONSOCKET, R.I. — CVS Health, the nation’s first and only national pharmacy chain to have eliminated the sale of tobacco products from its retail stores, today announced its support for the U.S. Food and Drug Administration’s plans to restrict access to flavored tobacco and e-cigarette products in the retail setting and impose stricter age-verification requirements for
WOONSOCKET, R.I. — As the nation’s first and only national pharmacy chain to have eliminated the sale of cigarettes and other harmful tobacco products from its retail stores and having never sold e-cigarettes and vaping devices CVS Health today applauded the enforcement actions taken by the U.S. Food and Drug Administration (FDA) to curtail the
WASHINGTON — Facing a national shortage of EpiPens, the Food and Drug Administration has extended the expiration dates of certain lots of the life-saving allergy drug by four months. The extensions apply to the 0.3 mg dose of EpiPen and its authorized generic, with current expiration dates between April and December 2018, according to a statement
WASHINGTON — Pharmaceutical Care Management Association (PCMA) president and chief executive officer Mark Merritt released the following statement on the Food and Drug Administration’s (FDA) new Biosimilars Action Plan: “We applaud the FDA for taking important steps toward approving more biosimilars in the United States. We are encouraged the FDA has designed a system that allows manufacturers
NEW YORK — Driven by the 21st Century Cures Act, Food and Drug Administration Commissioner Scott Gottlieb has publicly stated a goal of moving the FDA into the new century by creating a regulatory process that is modern and efficient. It doesn’t seem all that long ago, about 1992, that the Prescription Drug User Fee
https://www.chaindrugreview.com/app/uploads/2018/05/IMVEXXY_MNR_ABOUT_IMVEXXY.mp4 SEATTLE — Amazon.com has hired Taha Kass-Hout, the Food and Drug Administration’s first chief health informatics officer, according to published reports. Kass-Hout will serve in a business development role with the company’s Amazon Grand Challenge team, the reports say, and will concentrate on developing projects for the health care market. His exact mission, like the
WASHINGTON — The Food and Drug Administration today announced two new steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of
SILVER SPRING, Md. — The Food and Drug Administration has issued a warning that homeopathic teething tablets and gels may present a health risk to infants and children. The FDA on Friday urged consumers to stop using the products and dispose of any that they have. The agency said the homeopathic teething tablets and gels