Thursday, October 1, 2015

FDA will destroy banned imported drugs - Modern Healthcare

Updated June 16, 2025

The original link broke.

You can still read about this same topic on this FDA webpage:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-imports

---  the original post follows below  ---

Read the full article: FDA will destroy banned imported drugs - Modern Healthcare Modern Healthcare business news, research, data and events:

"Federal regulators will begin destroying some medications that can't be imported into the U.S.​ because of quality concerns.

Beginning Oct. 15, the U.S. Food and Drug Administration will destroy a drug that wasn't allowed into the U.S. because it's been found to have been “adulterated, misbranded or unapproved” and in violation of the Food, Drug and Cosmetic Act. The policy covers a drug if the value of a single dose is $2,500 or less. "

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Thursday, September 24, 2015

WHO Training Guide To GMPs - FREE

This is a wonderful free resource for those involved in or responsible for delivering GMP training or classroom sessions. The World Health Organization (WHO) published this guide, so that it could "help both trainers and supervisors solve some of the problems they face involving training, such as how to make the training interesting to adult learners or how to effectively use a variety of instructional methods."

A WHO Guide To Good Manufacturing Practice (GMP) Requirements, Part 3: Training (PDF), is organized by the following major chapters:
  1. Introduction and purpose of this guide
  2. The importance of training
  3. Types of training and content areas
  4. Developing and implementing training
  5. Assessment and evaluation
  6. Administrating a training programme
  7. Questionnaire
#FDA #cGMP #GMP #training #WHO

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Friday, September 18, 2015

The Fake Drug Industry Is Exploding, and We Can’t Do Anything About It - Newsweek


Read this enlightening article: The Fake Drug Industry Is Exploding, and We Can’t Do Anything About It - Newsweek:

. . ."many experts believe that the problem is on the rise and that more criminals are turning to pharmaceuticals for a simple reason: low risk and high reward. “The penalties are relatively weak for trading in falsified pharmaceuticals compared to those for trade in narcotics and human trafficking,” says Paul Newton, a professor of tropical medicine at the University of Oxford medical school who has spent decades tracking poor-quality medicines. And criminals can make a lot of money by falsifying drugs that are in high demand, in short supply or are exorbitantly expensive for consumers."

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Thursday, September 17, 2015

Robert Califf Could Transform The FDA -- The Right Way - Forbes


Read the full article: Robert Califf Could Transform The FDA -- The Right Way - Forbes:

"People who care about making sure that medicines and medical devices are safe and effective should be cheering the nomination of Robert Califf to be the new commissioner of the Food and Drug Administration, and any senators who slow his path to the job he deserves should be accused of practicing the basest kind of partisanship."

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Wednesday, September 16, 2015

Obama to Nominate Robert Califf to Lead FDA - WSJ

Updated August 8, 2026

You might also be interested in:

Office of the Commissioner:
https://www.fda.gov/about-fda/fda-organization/office-commissioner

- - -  original blog post follows below  - - -

Read the full article: Obama to Nominate Robert Califf to Lead FDA - WSJ:

"President Barack Obama plans to nominate the prominent cardiologist and medical researcher Robert Califf as the next commissioner of the Food and Drug Administration, the White House said Tuesday.

Dr. Califf had been named the FDA’s deputy commissioner for medical products and tobacco—effectively the No. 2 post—in February. He joined the FDA from Duke University, where he had served as a professor of medicine, a leading pharmaceutical researcher and the vice chancellor for clinical and translational research."

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Tuesday, August 4, 2015

In a first, drug using 3D printing technology gets FDA nod | Reuters


Read the full article: In a first, drug using 3D printing technology gets FDA nod | Reuters:

"The U.S. Food and Drug Administration has, for the first time, approved a drug that uses 3D printing technology, paving the way for potential customization of drugs to suit patients' needs.

The drug, made by privately held Aprecia Pharmaceuticals Co, was approved for oral use as a prescription adjunctive therapy in the treatment of epilepsy, the company said on Monday."

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Monday, August 3, 2015

Request for Quality Metrics - FDA Guidance for Industry


The FDA has released a guidance document that includes an explanation of how the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) intend to collect data and use quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry.

Read the guidance:  FDA Request for QualityMetrics - Guidance for Industry (PDF)

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Thursday, July 9, 2015

FDA Amends Drug Shortage Regulations


Read the full text final rule: Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products:

"The rule requires all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States."

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Thursday, July 2, 2015