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.
The 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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IVD devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick.
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Wednesday, September 25, 2019
The FDA has announced a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz used to decrease the amount of acid created by the stomach.
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Wednesday, November 04, 2020
The FDA is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2.
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The FDA has updated two guidances for the temporary compounding of certain human drugs during the COVID-19 public health emergency.
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Monday, September 30, 2019
The FDA is announcing an award granting a new five-year contract for the Sentinel System, the FDA’s flagship active surveillance system.
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Wednesday, October 30, 2019
The FDA issued a revised final guidance in January 2017, Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act, which is in place while the FDA develops the 503B...
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The 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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The FDA announced a change to the law will impact compounding of certain products beginning on March 23, 2020.
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The FDA is announcing the availability of a temporary guidance for industry entitled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers.”
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Tuesday, November 20, 2018
The FDA is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions due to lack of sterility assurance.
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The FDA took two significant actions in the agency’s ongoing and aggressive commitment to address the coronavirus outbreak (COVID19).
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Wednesday, October 14, 2015
The FDA is alerting health care professionals and patients of a voluntary recall of lots 1 through 67 of non-expired drug products intended to be sterile produced and distributed nationwide by Qualgen LLC, in Edmond, Okla., due to lack of sterility ...
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The FDA is alerting API repackagers and distributors, finished drug manufacturers, and compounders that Sichuan Friendly is recalling certain lots of porcine thyroid API due to inconsistent quality of the API.
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Wednesday, September 16, 2015
NVS Influenza Vaccines, now owned and operated by the CSL Limited, announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted to recommend licensure of a candidate ...
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