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, August 28, 2019
The FDA is reminding patients and health care professionals not to use drug products intended to be sterile made by Pacifico National, a facility doing business as AmEx Pharmacy.
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Wednesday, December 27, 2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
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The FDA has published a warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require ...
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The U.S. FDA announced it is requesting $7.2 billion as part of the President's fiscal year (FY) 2025 proposed budget.
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Wednesday, August 29, 2018
The FDA issued a Federal Register notice proposing not to include three bulk drug substances on the list of bulk drug substances that outsourcing facilities may use in compounding under section 503B of the 503B bulks list.
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Monday, November 12, 2018
The FDA announced the U.S. Marshals Service has conducted a mass seizure of FDA-regulated products being held under insanitary conditions in which they were exposed to widespread rodent, insect and live animal infestation.
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Monday, December 18, 2023
Checkpoint Therapeutics, Inc. disclosed that the FDA issued a Complete Response Letter (CRL) in connection with the cosibelimab biologic license application (BLA) intended for the treatment of individuals with metastatic or locally advanced cutaneous...
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Wednesday, October 23, 2019
The FDA has issued a warning letter to Jiangsu NHWA.
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Friday, September 21, 2018
The FDA has issued a warning letter to Pharmaceutical Laboratories and Consultants regarding several violations at the Illinois-based lab, including the presence of a microbrewery in its drug testing area.
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The FDA has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of CGMP regulations.
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Wednesday, October 19, 2016
FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research. Misconduct in clinical research, including, but not limited to the falsification ...
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Tuesday, October 29, 2019
One of the FDA's top priorities is to ensure that Americans have access to safe and effective medicines.
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Wednesday, August 07, 2019
Late last week, a U.S. District Court judge in Washington, D.C. issued a decision that upheld FDA’s interpretation of clinical need regarding the bulk substances that may be used by outsourcing facilities in drug compounding.
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The FDA is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs.
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As drug manufacturing has globalized, ensuring that companies meet the FDA strict standards for producing safe, effective and high-quality medicines has become increasingly challenging.
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