Pharmaceutical Outsourcing covers news of importance to the contract services segment of the pharmaceutical industry.
Collected from the most trusted on-line resources, these news stories are chosen and published here based on their relevance to the pharmaceutical industry.
Topics of interest typically include: mergers and acquisitions, service additions, new capabilities, personnel changes, news from the FDA and other international regulatory and standard-setting agencies, and new outsourcing contracts and deals.
If you are looking to stay up-to-date with the news in your industry, this resource is vital for your industry knowledge.
Update from the FDA on the continued efforts to mitigate the IV saline and amino acids for injection shortages exacerbated by Hurricane Maria.
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Wednesday, February 19, 2020
The FDA plays an essential role in overseeing our Nation’s medical products as part of our vital mission to protect and promote public health, including during public health emergencies.
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Monday, November 12, 2018
Manufacturing inspections are one of the FDA’s most important tools for ensuring the quality of pharmaceutical products used by American patients.
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Friday, February 08, 2019
The FDA is launching a pilot project in which participants representing the drug supply chain can pilot the use of innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the U.S. to ensure suspect and ...
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A critical focus for the FDA is preventing and mitigating potential medical product shortages.
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Testing remains an important cornerstone of our nation’s fight against COVID-19.
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The FDA has announced it will inactivate listing records in its database that have not been recently updated or certified or that include an establishment with an expired registration.
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Wednesday, November 01, 2017
The FDA has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements.
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During this COVID-19 pandemic, the FDA is working around the clock to make sure that Americans have access to safe food and medical products.
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The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical ...
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Tuesday, September 10, 2019
The FDA’s compounding program aims to help protect patients from poor-quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.
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As drug manufacturing has globalized, ensuring that companies meet the FDA strict standards for producing safe, effective and high-quality medicines has become increasingly challenging.
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The FDA is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs.
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Wednesday, August 07, 2019
Late last week, a U.S. District Court judge in Washington, D.C. issued a decision that upheld FDA’s interpretation of clinical need regarding the bulk substances that may be used by outsourcing facilities in drug compounding.
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Tuesday, October 29, 2019
One of the FDA's top priorities is to ensure that Americans have access to safe and effective medicines.
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