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.
Wednesday, August 26, 2020
The FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products.
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Wednesday, April 08, 2020
The U.S. Food and Drug Administration (FDA) has released the following statement regarding the current compounding policy.
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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 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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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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Wednesday, October 23, 2019
The FDA has issued a warning letter to Jiangsu NHWA.
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Friday, September 21, 2018
The FDA has issued a warning letter to Pharmaceutical Laboratories and Consultants regarding several violations at the Illinois-based lab, including the presence of a microbrewery in its drug testing area.
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The FDA has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of CGMP regulations.
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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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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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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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