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FDA

CHPA petitions FDA to establish a clear path for CBD in dietary supplements

CHPA petitions FDA to establish a clear path for CBD in dietary supplements

WASHINGTON — The Consumer Healthcare Products Association (CHPA) submitted on Thursday a citizen petition to the U.S. Food and Drug Administration (FDA) urging the agency to exercise its existing statutory authority to swiftly issue regulations that establish a clear pathway for manufacturers to lawfully market cannabidiol (CBD) in dietary supplements. “Intense consumer demand and commercial interest

Scott Gottlieb to keynote PLMA opening breakfast

Scott Gottlieb to keynote PLMA opening breakfast

ROSEMONT, Ill. —  Dr. Scott Gottlieb, who served as commissioner of the Food and Drug Administration from 2017-2019, will deliver the keynote for the opening breakfast at the Private Label Manufacturers Association’s 2019 Private Label Trade Show at the Rosemont Convention Center on Monday, November 18. Gottlieb, who drew plaudits from Democrats and Republicans alike for his

Trump administration looks to ban flavored e-cigarettes

Trump administration looks to ban flavored e-cigarettes

WASHINGTON — The Trump administration on Wednesday announced plans to remove all flavored e-cigarettes from store shelves in an ever widening crackdown on vaping, as officials warned that sweet flavors had drawn millions of children into nicotine addiction. President Trump and top U.S. officials expressed major concerns about surging teenage use of e-cigarettes, and the

Walmart working with IBM, Merck on new Rx program

Walmart working with IBM, Merck on new Rx program

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

Sharpless named acting FDA commissioner

Sharpless named acting FDA commissioner

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

Gottlieb resigns as FDA commissioner

Gottlieb resigns as FDA commissioner

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

WBA willing to meet with FDA over tobacco sales to minors

WBA willing to meet with FDA over tobacco sales to minors

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

FDA issues statement on new policy for pricing of generic drugs

FDA issues statement on new policy for pricing of generic drugs

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,

CVS applauds FDA restricting flavored tobacco products

CVS applauds FDA restricting flavored tobacco products

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

CVS praises FDA’s steps to curtail sales of e-cigarettes to nation’s youth

CVS praises FDA’s steps to curtail sales of e-cigarettes to nation’s youth

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

FDA extends EpiPen expiration date to combat shortage

FDA extends EpiPen expiration date to combat shortage

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

PCMA issues statement on FDA biosimilar action plan

PCMA issues statement on FDA biosimilar action plan

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