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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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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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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WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products - GDP Group

• Respected FDA cGMP online training programs and courses taught by SkillsPlus International Inc.

View the article with multiple links:  GMP News: WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products - GDP Group, an ECA Foundation Interest Group:

"For those working in the area of Good Distribution Practice (GDP) the following paper might be interesting: Technical supplements to Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products."

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Who Offers GMP Training?

Updated March 10, 2021

Given the COVID-19 pandemic, people also search for:

Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

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Who Offers GMP Training?

SkillsPlus International Inc. offers highly respected cGMP training. Here's why you need to choose SkillsPlus Intl Inc.:

SkillsPlus Intl Inc. can be your one-stop shop that: meets your needs, wows students, and makes your training delivery easier!

Visit SkillsPlus Intl Inc. training products & services, or call (415) 948-5220.

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