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.
Today, we are providing an update on the status of U.S. Food and Drug Administration inspections outside of the U.S. in response to the COVID-19 outbreak.
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The FDA has released draft guidance for industry “Labeling for Biosimilar Products.” This guidance provides an overview of FDA’s recommendations for biosimilar product labeling and is intended to assist industry in developing draft labeling for ...
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FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the COVID-19 pandemic.
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Wednesday, September 16, 2020
The FDA has issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency.”
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Tuesday, February 04, 2020
The FDA has posted laboratory results showing N- Nitrosodimethylamine (NDMA) levels in some metformin products approved in the U.S.
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Tuesday, February 25, 2020
The Secretary of HHS has delegated to FDA the authority to determine whether particular tests are "simple" and have "an insignificant risk of an erroneous result" under the CLIA of 1988 and are thus eligible for waiver categorization.
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Thursday, February 28, 2019
One of today’s most important tools for modernizing the pharmaceutical industry is a process known as continuous manufacturing (CM).
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Monday, December 23, 2019
Compounded drugs can serve an important role in meeting patients’ medical needs that cannot be met by an FDA-approved drug.
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The opioid tragedy has become one of the defining public health crises of modern times.
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Friday, December 06, 2019
The FDA has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs.
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A communication from the FDA has been released to clarify the timing of FDA's implementation of new reporting requirements for manufacturing volume data under section 3112(e) of the CARES Act.
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The FDA is warning consumers and health care professionals about certain hand sanitizer products, including are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination.
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DILIsym Services announced the FDA has renewed its multi-seat license for the company’s flagship quantitative systems toxicology modeling software, DILIsym®.
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Wednesday, September 25, 2019
Certara® announced the FDA has renewed licenses for Synchrogenix’s electronic Common Technical Document review software, GlobalSubmit REVIEW™ and GlobalSubmit VALIDATE™.
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The U.S. Food & Drug Administration (FDA) scientists recently discovered an inaccuracy in certain data provided to the agency by the IQVIA National Sales Perspectives database, including data on certain opioid drug products.
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