FDA News

Juul Soon to Be Ordered Off the Market by FDA, WSJ Reports

The US Food and Drug Administration is getting ready to order Juul Labs Inc.’s e-cigarettes off the market, the Wall Street Journal reported, citing people familiar with the matter. The decision could be announced as early as Wednesday, according to …

Whistleblower Suing Eli Lilly Alleges Drug Manufacturing Problems

A former human resources officer at Eli Lilly & Co. sued the pharmaceutical company on Monday, alleging she was terminated after pointing out poor manufacturing practices and data falsification involving its blockbuster diabetes drug. The plaintiff, Amrit Mula, alleges violations …

U.S. Product Recalls Reach 10-Year High in Q1

Over 900 million units were recalled during the first quarter in the United States in the automotive, consumer products, food and drink, pharmaceutical, and medical device industries according to Sedgwick’s latest quarterly Recall Index. Segdwick’s brand-protection experts said it is …

FDA Chief Struggles to Explain Slow Response on Baby Formula

The head of the Food and Drug Administration faced bipartisan fury from House lawmakers May 25 over months of delays investigating problems at the nation’s largest baby formula plant that prompted an ongoing shortage. FDA Commissioner Robert Califf laid out …

FDA Details Problems at Plant Behind Recalled Baby Formula

Baby formula maker Abbott failed to maintain sanitary conditions and procedures at the Michigan manufacturing plant recently linked to a cluster of infant illnesses, according to findings released Tuesday by federal safety inspectors. The Food and Drug Administration posted its …

Louisiana Governor Sticks with Vaccine Plan Despite Opposition

An outpouring of legislative opposition and a likely threat of litigation aren’t changing Gov. John Bel Edwards’ mind about requiring some Louisiana students to get the COVID-19 vaccine during the next school year or file a written opt-out form. The …

FDA Proposes Stricter Traceability Rules for Certain Food Products

This post is part of a series sponsored by Worldwide Facilities, LLC. The ability to trace where food originally came from allows authorities to better contain and manage contamination when it occurs. Recently, the Food and Drug Administration (FDA) has …

Some Baby Foods Found to Contain High Levels of Toxic Heavy Metals

U.S. congressional investigators found “dangerous levels of toxic heavy metals” in certain baby foods that could cause neurological damage, a House Oversight subcommittee said in a report released on Thursday in calling for new standards and testing requirements. The panel …

U.S. Drug Regulator Vows Outside Review of Any COVID-19 Vaccines

The United States will need to have independent experts review COVID-19 vaccine candidates before approval, the country’s top drug regulator said on Friday, offering reassurance that his agency would not cut corners in the race to roll out a vaccine. …

Fears of ‘Wild West’ as Unregulated COVID-19 Tests Hit the Market

Blood tests for the coronavirus could play a key role in deciding whether millions of Americans can safely return to work and school. But public health officials warn that the current “Wild West” of unregulated tests is creating confusion that …