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 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, 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The FDA has announced the availability of a draft guidance for industry that is applicable to holders of approved new drug applications, ANDAs, new animal drug applications, abbreviated new animal drug applications and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 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, 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 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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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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As previously disclosed, Albany Molecular Research, Inc. received a warning letter, dated August 17, 2010, from the U.S. Food and Drug Administration (FDA) in connection with the FDA’s inspection of the Company’s pharmaceutical manufacturing ...
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Federal health advisers on Tuesday recommended approval for a highly anticipated cholesterol drug from Sanofi and Regeneron Pharmaceuticals, but with the caveat that more data is needed about its long-term ability to reduce heart attacks.
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WASHINGTON (AP) — The drug industry's decade-spanning search for a female equivalent to Viagra took a major step forward Thursday, as government experts recommended approval for a pill to boost sexual desire in women.
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The agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in approximately six months.
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Wednesday, September 16, 2015
The FDA is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe ...
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Wednesday, August 12, 2015
The Food and Drug Administration says Kardashian's social media posts violate federal drug-promotion rules.
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Wednesday, January 29, 2020
The FDA has issued a warning letter to Sunstar Guangzhou following the inspection of the company’s drug manufacturing facility.
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Recently. FDA issued the DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy Guidance. This document announces that FDA does not intend to take enforcement action against dispensers who, prior to November 1, 2015:
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The FDA issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.
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