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The FDA has issued a draft guidance for industry, “Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment,” to assist drug companies in the clinical development of drugs for the treatment of X-linked Duchenne ...
read more
The FDA issued an EUA for the third vaccine for the prevention of COVID-19.
read more
Wednesday, February 05, 2020
The FDA issued an emergency use authorization to enable emergency use of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel.
read more
ChromaCode announced that the FDA has granted EUA of ChromaCode's HDPCR™ SARS-CoV-2 Real-Time PCR Assay.
read more
The FDA issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.
read more
Tuesday, January 26, 2021
The FDA has issued a guidance to notify drug manufacturers, including repackers, relabelers, alcohol suppliers and compounders, of FDA’s policy on testing of alcohol or isopropyl alcohol for methanol prior to using the ingredient in drugs.
read more
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.
read more
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:
read more
Wednesday, January 29, 2020
The FDA has issued a warning letter to Sunstar Guangzhou following the inspection of the company’s drug manufacturing facility.
read more
Wednesday, August 12, 2015
The Food and Drug Administration says Kardashian's social media posts violate federal drug-promotion rules.
read more
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 ...
read more
The agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in approximately six months.
read more
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.
read more
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.
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