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Tag: FDA Regulations

21
Dec, 2016
21st Century Cure

21st Century Cures Act Signed Into Law

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

After stalling in the Senate for over a year, the 21st Century Cures Act was passed by Congress and signed into law by President Obama. The sweeping new legislation...

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20
Dec, 2016
Warning Letters

FDA Sends Warning Letters Over TV Commercials

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

The FDA’s Office of Prescription Drug Promotion has been relatively quiet this year, but it appears the Agency is ending 2016 with a bang. The Office of Prescription Drug...

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02
Dec, 2016
Infection Risk

FDA Delay Exposed Patients To Infection Risk

  • By
  • Andrew Steinberg
  • |
  • Defective Medical Devices,FDA News & Recalls
  • |
  • 0 Comments

After Vincent Karst underwent open-heart surgery in early 2015, he seemed to recover well and his life slowly returned to normal. However, he slowly began to suffer from shortness...

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30
Nov, 2016
Defective Medical Device Reporting

Do Hospitals Know The Defective Medical Device Reporting Requirements?

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

Hospitals have a responsibility to report any adverse event related to medical devices to the U.S. Food and Drug Administration (FDA), but a recent investigation found many hospitals are...

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15
Nov, 2016
off label

Should The FDA Allow Companies To Promote Drugs For Off Label Uses?

  • By
  • Andrew Steinberg
  • |
  • Drug & Device Manufacturers,FDA News & Recalls
  • |
  • 0 Comments

The U.S. Food and Drug Administration (FDA) is often criticized for stifling medical innovation, but a conference that took place earlier this week has some worried the federal agency...

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01
Nov, 2016

Patients Can Now Report Defective Medical Devices To The FDA Online

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

The laws regarding the reporting of potentially defective medical devices are spotty at best. Doctors themselves are not required to report adverse events to the FDA. Their participation is...

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26
Oct, 2016
Medical Device Applications

Are Hospitals Under-Reporting Defective Medical Devices?

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

Under federal law, hospitals must report adverse events related to medical devices to the U.S. Food and Drug Administration (FDA). Doing so will help the FDA identify potentially defective...

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05
Oct, 2016
device manufacturers

Are Priority Review Vouchers Safe?

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

The process of receiving approval from the U.S Food and Drug Administration (FDA) is long and expensive. Critics in the pharmaceutical industry complain the process deters advances in medicine...

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22
Sep, 2016
medical device tracking

Medical Device Tracking IDs Could Save Lives If Hospitals Could Use Them

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 1 Comments

Nine years ago, Congress passed an important piece of legislation requiring unique medical device identifying numbers on all medical devices. The law requires manufacturers to label each medical device,...

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19
Sep, 2016
cosmetics

FDA Cracking Down On Cosmetic Industry

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

The U.S. Food and Drug Administration usually spends its time reviewing medical devices or inspecting food facilities, but lately the agency has taken on the cosmetic industry with more...

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