• Facebook
  • LinkedIn
  • Twitter
  • Youtube
  • TESTIMONIALS
  • BLOG
  • ARTICLES
Call us: 800-349-0127
Blizzard Law PLLC
  • Home
  • Our Firm ▼
    • Attorneys
    • Testimonials
  • Practice Areas ▼
    • ◂ Personal Injury
      • 18-Wheeler Accidents
      • First Responders Deer Park Fire Injuries
      • Industrial Accidents
      • Maritime Accidents
      • Wrongful Death
      • Workplace Injuries
    • ◂ Dangerous Drugs
      • ◂ Birth Defect Litigation
        • Celexa
        • Lexapro
      • Talcum Powder
      • Valsartan
    • ◂ Defective Devices
      • CPAP Recall Cancer Lawsuit
      • Hernia Mesh
      • IVC Filters
      • JUUL and Vaping Lawsuits
      • Minimally Invasive Brain Surgery
      • Transvaginal Mesh
    • ◂ Sexual Assault
      • Hotel Sexual Assault
      • USC OBGYN Assault
      • Sexual Assault Resources
    • ◂ Human Trafficking
      • Human Trafficking Resources
  • Blog
  • Contact Us
  • Menu Menu
new medications

FDA Paves The Way For More Drug Inspections Overseas

December 4, 2017/in Dangerous Drugs /by damg

There is a fine balance between providing lifesaving medicine to the public and protecting the public from potentially harmful medicine. This is the line the U.S. Food and Drug Administration (FDA) must walk as it regulates drugs and medical devices. However the agency is making tremendous strides in patient safety by allowing more drug inspections in manufacturing facilities overseas.

The FDA recently announced it is taking steps toward the implementation of the amended Pharmaceutical Annex to the 1998 U.S.-European Union (EU) Mutual Recognition Agreement (MRA). This agreement allows  regulators from both countries to use each other’s inspections of pharmaceutical manufacturing facilities to ensure they are meeting the appropriate health and safety standards. The FDA will now recognize the authority of drug regulatory agencies in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom to inspect facilities to see if they meet with FDA requirements.

This will have a huge impact on the availability of new medicines, as many medicines approved by the FDA are partially or completely manufactured overseas. Before recognizing these drug authorities, the FDA alone was responsible for overseas inspections. However, with massive numbers of drug companies and facilities, overseeing them all was a difficult task for the FDA.

The partnership prevents duplication of facility inspections, allowing more resources to be devoted to countries and facilities where there may be a greater risk of substandard manufacturing practices. By partnering with other countries, more facilities are inspected more often to ensure they are using good manufacturing processes.

Unfortunately, these overseas strides only seek to remedy a small part of what medications and devices can do to harm patients. Sometimes drugs meeting the FDA’s manufacturing requirements still cause significant injuries to patients. Oftentimes dangerous side effects are only discovered after a drug has hit the market. Drugs like anti-nausea medications and heartburn relievers can cause permanent injuries to unknowing patients.

What Patients Can Do

All medications and medical devices come with risks. However, patients have a right to know all of these risks upfront, so they can make informed decisions about their care. The FDA releases warning letters to the public when a manufacturer fails to meet FDA standards, including manufacturing standards and/or safety standards. Patients can look up the compliance history of any drug, manufacturer, or facility on the FDA’s website. By investigating the history of a drug or device, patients can make better informed decisions about their healthcare.

Tags: FDA
Share this entry
  • Share on Facebook
  • Share on Twitter
  • Share on WhatsApp
  • Share on Pinterest
  • Share on LinkedIn
  • Share by Mail
https://www.blizzardlaw.com/wp-content/uploads/2018/11/iStock_000017561537_Full-2.jpg 2033 3050 damg https://www.blizzardlaw.com/wp-content/uploads/2020/07/logo-blizzard-law-pllc-2-300x92.png damg2017-12-04 15:09:472019-11-07 17:01:45FDA Paves The Way For More Drug Inspections Overseas

CATEGORIES

  • Articles
  • Dangerous Drugs
  • Defective Devices
  • DWI
  • Hurricane Harvey Claims
  • Medical Malpractice
  • News
  • Personal Injury
  • Uncategorized

Recent Post

  • Trial Lawyer Anna Greenberg Earns Texas Rising Stars Honor March 22, 2023
  • New York Times Features Blizzard Law Case in Hotel Crime Report March 22, 2023
  • New York Post Features Blizzard Law Cases in Article Exposing Hotel Negligence Related to Sexual Assaults March 8, 2023
  • Hotel Owner to Pay Nearly $1 Million in Attempted Sexual Assault of Hotel Guest February 2, 2023
  • Annual Christmas send off party at JFK Elementary School in Houston December 21, 2022
  • Blizzard Law Attorneys Earn Best Lawyers in America Recognition  August 19, 2022
  • Blizzard Law Firm’s $44M Court Win Nabs No. 1 Ranking on Texas Lawyer’s Top Verdicts List for 2021 August 11, 2022
  • Blizzard Law files lawsuit on behalf of local student against a DoubleTree by Hilton hotel in North Austin May 19, 2022

WHAT PEOPLE SAY

I cannot say enough good things about my experience with Blizzard Law! As an out-of-state client, I was skeptical about obtaining first-rate representation for my sexual assault case. After my first meeting with Anna and Ed I knew I was in the right hands… ”

Kathleen Dawson blizzard law five stars

I am beyond grateful that Blizzard Law represented me, and specifically Anna Greenberg who guided and supported me through my journey. My case was unique and involved multiple parties and needed innovative, meticulous, and empathetic minds. I am confident that there is not a better team that could have fought my case, or any type of sexual assault case….”

H.M.blizzard law five stars
ALL TESTIMONIALS
Top Houston Litigation Attorneys

LET US KNOW ABOUT YOUR CASE

CALL US
800-349-0127 | 713-844-3750

CONTACT US MEET THE LAWYERS

ABOUT BLIZZARD LAW

Blizzard Law PLLC was founded by trial lawyers who wanted to take the skill and knowledge gained from representing large corporations and insurance companies and use it for the benefit of individuals injured by defective drugs and products.

QUICK LINK

Our Firm

Attorneys

Blog

Articles

Contact

PARTNER LOGO


CONTACT

5020 Montrose Blvd, Ste 410
Houston, TX 77006

LATEST NEWS

  • Trial Lawyer Anna Greenberg Earns Texas Rising Stars HonorMarch 22, 2023 - 7:16 pm
  • New York Times Features Blizzard Law Case in Hotel Crime ReportMarch 22, 2023 - 7:10 pm
  • New York Post Features Blizzard Law Cases in Article Exposing Hotel Negligence Related to Sexual AssaultsMarch 8, 2023 - 3:12 pm
  • Hotel Owner to Pay Nearly $1 Million in Attempted Sexual Assault of Hotel GuestFebruary 2, 2023 - 9:50 pm
Disclaimer: This is an advertisement. This web site is designed for general informational purposes only. This information or contacting me through this website does not create an attorney-client relationship.
© Copyright - Blizzard Law PLLC
  • Facebook
  • LinkedIn
  • Twitter
  • Youtube
  • AREAS SERVED
  • PRIVACY POLICY
  • DISCLAIMER
Texas Hasn’t Had A Day Without A Fatal Car Accident In 17 Years Fatal Car Accident Self-Driving Vehicles Are Self-Driving Vehicles Safer?
Scroll to top