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.
Aidoc announced the FDA has allowed the use of their cleared AI algorithms intended for adjunctive use in the detection of findings associated with COVID-19.
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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 is making its previously developed MyStudies app available to investigators to obtain informed consent securely from patients for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures...
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Wednesday, September 12, 2018
The FDA has announced the availability of a draft guidance for industry that is applicable to holders of approved new drug applications, ANDAs, new animal drug applications, abbreviated new animal drug applications and holders of drug master files ...
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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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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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Johnson & Johnson announced that the FDA Oncologic Drugs Advisory Committee (ODAC) recommends CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least...
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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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Today, we are providing an update on the status of U.S. Food and Drug Administration inspections outside of the U.S. in response to the COVID-19 outbreak.
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The FDA has released draft guidance for industry “Labeling for Biosimilar Products.” This guidance provides an overview of FDA’s recommendations for biosimilar product labeling and is intended to assist industry in developing draft labeling for ...
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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 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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