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, 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.
read more
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...
read more
Wednesday, October 23, 2019
The FDA has issued a warning letter to Jiangsu NHWA.
read more
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.
read more
The FDA has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of CGMP regulations.
read more
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 ...
read more
Tuesday, October 29, 2019
One of the FDA's top priorities is to ensure that Americans have access to safe and effective medicines.
read more
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.
read more
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.
read more
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.
read more
Tuesday, September 10, 2019
The FDA’s compounding program aims to help protect patients from poor-quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.
read more
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical ...
read more
During this COVID-19 pandemic, the FDA is working around the clock to make sure that Americans have access to safe food and medical products.
read more
Wednesday, November 01, 2017
The FDA has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements.
read more
The FDA has announced it will inactivate listing records in its database that have not been recently updated or certified or that include an establishment with an expired registration.
read more