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.
Wednesday, October 23, 2019
The FDA has issued a warning letter to Jiangsu NHWA.
read more
The FDA is warning consumers and health care professionals about certain hand sanitizer products, including are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination.
read more
A communication from the FDA has been released to clarify the timing of FDA's implementation of new reporting requirements for manufacturing volume data under section 3112(e) of the CARES Act.
read more
Friday, December 06, 2019
The FDA has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs.
read more
Thursday, February 28, 2019
One of today’s most important tools for modernizing the pharmaceutical industry is a process known as continuous manufacturing (CM).
read more
Tuesday, February 25, 2020
The Secretary of HHS has delegated to FDA the authority to determine whether particular tests are "simple" and have "an insignificant risk of an erroneous result" under the CLIA of 1988 and are thus eligible for waiver categorization.
read more
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.”
read more
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the COVID-19 pandemic.
read more
Wednesday, April 08, 2020
The U.S. Food and Drug Administration (FDA) has released the following statement regarding the current compounding policy.
read more
Wednesday, August 26, 2020
The FDA is providing a laboratory testing method to assess the quality of finished hand sanitizer products.
read more
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.
read more
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 ...
read more
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.
read more
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.
read more
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 ...
read more