This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

News
16 Mar 2011

Overseas Manufacturing Puts U.S. at Risk

More drugs approved in the U.S. are manufactured overseas. This makes FDA inspection rate drop.

FDA is having a hard time keeping up with inspections in the supply chain as many of the drugs approved in the U.S. are now manufactured overseas. The result could be another tainted-drug disaster just waiting to happen. This is not an FDA watchdog with an agenda sounding the alarm; the agency itself came out with the dire warning.

 

"The safety of America's food and medical products is under serious challenge," warned senior FDA official John Taylor, who was speaking at a Pew Health Group meeting. He raised the specter of "another public health crisis like Heparin." In 2008, contaminants in the blood thinner Heparin produced in China led t

Related News

  • News Swiss pharma industry warns US tariffs could harm global patient care

    The Swiss pharmaceutical sector has raised alarms over new US tariffs on medicines, warning of disrupted supply chains, increased costs, and delayed innovation, all of which could jeopardise patient access to essential treatments worldwide.

  • News Understanding the Benefits and Advances of Cleanroom Technology

    In an industry where precision and sterility are crucial concerns, cleanrooms play a vital role in maintaining the integrity of pharmaceutical products like drugs, vaccines, and other medical products. So, what is a cleanroom?

  • News From Pharma to Table? Direct-to-consumer pharma sales and price cuts ramp up in US

    The pharmaceutical industry is witnessing a seismic shift as major companies embrace direct-to-consumer sales models and announce significant price reductions across the United States, responding to mounting pressure from the Trump administration to ta...
  • News A Day in the Life of a Director of Business Development

    In this Day in the Life of interview, Thomas Hauser, Director of Business Development at Tjoapack. Thomas has spent nearly 30 years in the pharmaceutical industry and describes how he still finds curiosity and excitement in the bigger picture of global...
  • News Women in Pharma: Our hopes for 2025 and beyond

    Our last instalment for 2024 of the Women in Pharma series brings you messages direct from the Informa Markets CPHI team as they discuss the advice and insights they have carried throughout their roles working at CPHI, and what they hope to see for the...
  • News CPHI Milan 2024 - From the Floor

    Milan and CPHI welcome you to 2024 CPHI Milan! As we celebrate the 35th edition of our flagship CPHI show, editors Vivian Xie and Lucy Chard bring you the latest from the show floor, conference sessions, and innovative solutions from all exhibitors, at...
  • News The BIOSECURE Act: implications for the pharma supply chain

    On September 9, 2024, the US House of Representatives voted to pass the bill titled the BIOSECURE Act (the Act), which lists several Chinese companies in the pharmaceutical supply chain. The Act will prohibit American companies from contracting or doin...
  • News A Day in the Life of a Global CDMO Chapter Lead – Manufacturing

    The 'Day in the Life of' series has covered many aspects of the pharmaceutical pipeline, including R&D and procurement, now we're taking a look at manufacturing from a global CDMO perspective.