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.
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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Wednesday, August 28, 2019
The FDA is reminding patients and health care professionals not to use drug products intended to be sterile made by Pacifico National, a facility doing business as AmEx Pharmacy.
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Wednesday, December 27, 2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
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The FDA has published a warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require ...
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The U.S. FDA announced it is requesting $7.2 billion as part of the President's fiscal year (FY) 2025 proposed budget.
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Wednesday, August 29, 2018
The FDA issued a Federal Register notice proposing not to include three bulk drug substances on the list of bulk drug substances that outsourcing facilities may use in compounding under section 503B of the 503B bulks list.
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