Food and Drug Administration

BoxC links with FDA for faster e-commerce customs clearance

Global shipping platform BoxC announced that through a data-sharing initiative with U.S. Customs and Border Protection its e-commerce merchants shipping Food and Drug Administration-regulated products will have the capability to send products individually to the U.S. and receive the same clearance rate as bulk shipping.

Chad Schofield, co-founder and chief digital officer at BoxC, told FreightWaves the difficulties e-commerce shippers face when getting their products into the United States.

“Tradi...

Bubs baby formula from Australia gets FDA import approval

Twin babies on their back being fed from bottles.

The Biden administration on Friday took two more actions aimed at alleviating a critical domestic shortage of baby formula.

The Food and Drug Administration gave the green light to an Australian company to import its baby formula after relaxing strict regulatory requirements aimed at alleviating a critical domestic shortage. Also, Xavier Becerra, the Health and Human Services secretary, invoked the Defense Production Act for the third time in less than a week to help Cargill deliver raw...

https://www.freightwaves.com/news/bubs-baby-formula-from-australia-gets-fda-import-approval

What price will the supply chain pay for resiliency?

At one time, a factory in Denmark run by pharmaceutical firm Novo Nordisk A/S (ADR: NVO) made half of the world’s supply of insulin. Vowing to never run short of a product that people’s lives depended upon, Novo kept a five-year supply in the deep freeze.

Few companies will go to such lengths to maintain optimal inventory levels. However, the anecdote is instructional, especially in light of recent events: While there’s a price to be paid for building resilience into supply chains, there is an...

https://www.freightwaves.com/news/what-price-will-the-supply-chain-pay-for-resiliency

Can 3D printing help the US prepare for the next pandemic?

A volunteer assists at a COVID-19 testing site in Virginia. (Photo: HHS)

This is an excerpt from Medically Necessary, a health care supply chain newsletter. Subscribe here.

The story: Thousands of small businesses, schools and enthusiasts came out of the woodwork last year to produce personal protective equipment with 3D printers. 

A recently released report found that those nontraditional producers filled a critical gap early in the COVID-19 pandemic. 

The report, conducted by America Makes, suggests increasing government funding to boost the production capacity of 3D...

https://www.freightwaves.com/news/can-3d-printing-help-the-us-prepare-for-the-next-pandemic

FDA took exceptional steps to prevent drug shortages last year

(Photo: Artem Podrez)

This is an excerpt from Medically Necessary, a health care supply chain newsletter. Subscribe here.

The news: The Food and Drug Administration used tools like regulatory flexibility and expedited applications to avoid nearly 200 drug shortages in 2020, according to a new report.

The agency hasn’t prevented that many shortages since 2012, when the problem was more severe.

In the midst of a pandemic that dramatically increased demand for some drugs, the FDA took far more actions to avoid shortages...

https://www.freightwaves.com/news/fda-took-exceptional-steps-to-prevent-drug-shortages-last-year

Problematic vaccine plant still lacks approval after some doses cleared

(Photo: Department of Health and Human Services)

The news: A problematic Maryland vaccine plant making Johnson & Johnson’s COVID-19 vaccine still doesn’t have regulatory approvals, even after the Food and Drug Administration declared several batches from the plant were safe.

FDA on June 11 cleared two batches of the Johnson & Johnson vaccine produced at the plant, and cleared a third batch this week.

The FDA has cleared a total of 25 million Johnson & Johnson doses from the Maryland plant, according to The Wall Street Journal. Additional...

https://www.freightwaves.com/news/problematic-vaccine-plant-still-lacks-approval-after-some-doses-cleared

Commentary: Washington must quickly build confidence in vaccine supply chain

The jubilation Americans felt about the speed with which Pfizer and BioNTech, Moderna, AstraZeneca and Oxford University, and other groups developed their respective versions of a vaccine for COVID-19 has met the cold, hard reality of just how complex supply chains can be.

On one hand we read about how Israel has vaccinated 20% of its population within three weeks. On the other hand we are confronted with record deaths from COVID-19 in the United States in the midst of a very slow start to the...

https://s29755.pcdn.co/news/commentary-washington-must-quickly-build-confidence-in-vaccine-supply-chain

Join Our Newsletter
Enter your email to receive a weekly round-up of shipping news.
icon
By subscribing, you agree with our privacy policy and our terms of service.