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.
Monday, February 01, 2016
Eagle Pharmaceuticals has announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to its RYANODEX® (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke (“EHS”), an ...
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Tuesday, October 06, 2015
Bristol-Myers Squibb has announced that the FDA has accepted for filing and review three supplemental New Drug Applications (sNDAs) for Daklinza(daclatasvir), an NS5A replication complex inhibitor, for use with sofosbuvir with or without ribavirin.
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Glenmark has received a CRL from the FDA for Ryaltris™ (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray.
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Wednesday, September 04, 2019
The FDA has issued a Complete Response Letter for the New Drug Application for Insulin Glargine filed by the company’s partner, Mylan.
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The FDA took two additional significant diagnostic actions during the coronavirus outbreak by issuing EUAs to: Hologic and LabCorp.
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The FDA has issued a draft guidance for industry, “Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment,” to assist drug companies in the clinical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 ...
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The FDA issued an EUA for the third vaccine for the prevention of COVID-19.
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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.
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ChromaCode announced that the FDA has granted EUA of ChromaCode's HDPCR™ SARS-CoV-2 Real-Time PCR Assay.
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The FDA issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.
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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.
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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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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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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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Wednesday, August 12, 2015
The Food and Drug Administration says Kardashian's social media posts violate federal drug-promotion rules.
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