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, 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 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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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 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, 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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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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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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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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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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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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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 has announced the retirement of the MedWatch to Manufacturer Program.
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Patients expect and deserve high-quality drugs – this means consistently safe and effective medicines, free of defects and contamination.
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Wednesday, January 13, 2016
Last year was an exceptionally strong year for biopharmaceutical innovation as the U.S. Food and Drug Administration (FDA) approved 45 new medicines – the highest number of approvals in almost two decades - giving patients even greater hope for the ...
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Thursday, November 21, 2019
The FDA approved Abrilada (adalimumab-afzb), the 5th biosimilar to U.S.-licensed Humira (adalimumab).
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