Multiple drugs used to treat patients in hospital and clinical settings nationwide are being recalled because they did not ...
New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...
Regulatory approval is a major milestone in the drug development process, but it is not the final chapter in the journey.
The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers and compounders for ...
Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...
Chuck Berry’s 1959 hit, “Back in the U.S.A.” came to mind as we reviewed the Food and Drug Administration’s recent move to bolster the resilience of the U.S. pharmaceutical supply chain by introducing ...
Opportunities in the pharmaceutical API manufacturing market include leveraging rising demand for complex biologics, ...
Amid a trade war that could strain imports of lifesaving pharmaceuticals, President Donald Trump wants to ease regulations and bolster domestic drug manufacturing. The president signed an order on May ...
Our FDA: Compliance & Enforcement Team explores the U.S. Food and Drug Administration’s new draft guidance on responding to FDA Form 483 observations at the conclusion of an inspection. The FDA’s ...
The life sciences, and in particular, the pharmaceutical supply chain, are far more complex than other products and industries. Pharmaceuticals and other medical products require unique compliance ...
President Trump wants pharmaceutical production to return to the United States. A shuttered factory in Louisiana shows how hard that will be for generic medicines. Dr. Reddy’s, an Indian generic ...
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