Former FDA Chief Gottlieb Heads to Pfizer’s Board: Brainstorm Health

Good afternoon, readers – and a short one for you amid some busy times. Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb abruptly resigned from his post earlier this year following a tenure marked by aggressive changes is drug approval, digital health, and tobacco policy. On Thursday, he announced he’s already got a new […]

FDA Proposes Changes to Breast Cancer Screenings for Women With Dense Breasts

The Food and Drug Administration announced on Wednesday proposed changes to breast-cancer screening standards that would require mammogram providers to tell women whether they have dense breast tissue that can make detection of cancer more difficult. The proposal marks the biggest change in mammogram standards in two decades. FDA Commissioner Scott Gottlieb said the proposal […]

8 More Kinds of Dog Food Recalled for Potentially Toxic Vitamin D Levels

Go into Saturday’s National Puppy Day with caution: Hill’s Pet Nutrition announced its voluntarily recalling eight different kinds of canned dog food for potentially toxic levels of Vitamin D. (1/3) We are deeply sorry to announce that we are expanding our 1/31/19 canned dog food recall associated with elevated levels of vitamin D. To check […]

FDA Chief Scott Gottlieb Calls for Tighter Regulations on Electronic Health Records

Food and Drug Administration Commissioner Scott Gottlieb on Wednesday called for tighter scrutiny of electronic health records systems, which have prompted thousands of reports of patient injuries and other safety problems over the past decade. “What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re […]

FDA Approves First Drug Treatment for Postpartum Depression

The U.S. Food and Drug Administration (FDA) has approved a drug for the first time that aims at treating postpartum depression in mothers. Dubbed Zulresso, the medication is administered by a continuous intravenous (IV) infusion for 60 hours. According to the FDA, the IV must be administered in a health care facility because of fears […]

FDA Recalls Losartan Lots, Another Blood Pressure Drug Contaminated With a Cancer Causing Impurity

The United States Food and Drug Administration (FDA) has issued more recalls for the blood pressure medication losartan. The latest recall notices were issued on Friday as two separate, voluntary recalls, both being issued in conjunction with Missouri-based Legacy Pharmaceuticals Packaging, LLC. No adverse effects related to these recalled hypertension drugs have been reported. Lists […]

Kind Bars Petitions the FDA to Change How it Regulates Food Labels

The maker of Kind bars is asking the Food and Drug Administration to reconsider how it regulates food labels. The nutbar company filed a petition Wednesday with the FDA. The issue stems in part from the use of the word “healthy.” Kind had previously used the word on its labels; however, in 2015 the FDA […]

Trump Administration Makes Surprising Choice for FDA Interim Chief: a Career Scientist

Norman “Ned” Sharpless was named as interim head of the Food and Drug Administration Tuesday. Sharpless, the director of the National Cancer Institute, is a scientist, making the appointment a departure from the Trump administration’s pattern of appointing industry insiders and lobbyists to head federal agencies. Sharpless has served as the director of the NCI […]

The FDA Calls Out 15 Retailers For Selling Tobacco to Minors

The Food and Drug Administration has put 15 national retailers on notice for allegedly selling tobacco products to minors including Walgreens, Walmart, Kroger, and 7-Eleven. FDA Commissioner Scott Gottlieb said that he plans to contact the companies in question and ask them about their policies regarding tobacco sales and where they plan to improve, CNBC […]