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 has been determining the safest and most appropriate time to resume prioritized domestic inspections of FDA-regulated facilities and other associated activities since we first announced postponement in March.
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Wednesday, August 05, 2020
The FDA proposed to include four bulk drug substances on the list of bulk drug substances that outsourcing facilities may use in drug compounding consistent with section 503B of the Federal Food, Drug & Cosmetic Act.
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The FDA has proposed to include one additional bulk drug substance on the list of bulk drug substances that outsourcing facilities may use in drug compounding consistent with section 503B of the Federal Food, Drug and Cosmetic Act.
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To reduce the risk of death from opioid overdose, the FDA is making the following recommendations about the opioid reversal medicine, naloxone.
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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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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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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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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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Wednesday, October 23, 2019
The FDA has issued a warning letter to Jiangsu NHWA.
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Wednesday, February 19, 2020
The FDA plays an essential role in overseeing our Nation’s medical products as part of our vital mission to protect and promote public health, including during public health emergencies.
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Update from the FDA on the continued efforts to mitigate the IV saline and amino acids for injection shortages exacerbated by Hurricane Maria.
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The FDA has issued warning letters to three repackers of API for significant violations of current good manufacturing practice (CGMP) requirements.
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Tuesday, October 15, 2019
The FDA has posted a warning letter to Torrent Pharmaceuticals in Ahmedabad, Gujarat, India.
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Wednesday, September 02, 2020
The FDA and the FTC has issued a warning letter to Lattice Biologics for marketing an unapproved amniotic fluid product, sometimes referred to as AmnioBoost.
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Wednesday, March 11, 2020
The FDA and the FTC issued warning letters to seven companies for selling fraudulent COVID-19 products.
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