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The FDA issued final guidance on dissolution testing for immediate-release solid oral dosage form drugs containing high solubility substances. Read More
The FDA finalized its recommendations on how drug sponsors submitting applications should control elemental impurities in their drug products. Read More
The FDA issued Form 483s to U.S. and foreign drugmakers, citing violations for sanitation issues, unreliable data and nonconformances, among other observations. Read More
Drug sponsors and investigators should work with organizations that offer either interoperable or integrated electronic health records or electronic data capture systems, the FDA said in a final guidance. Read More
The FDA released draft guidance on field alert reports, using a Q&A format to outline the responsibilities of drug applicants for FAR submissions. Read More
The FDA released draft guidance outlining the information sponsors should include on the Indications and Usage section of drug and biologics labeling. Read More
The FDA slapped three drug manufacturers — including two Chinese firms — with warning letters after the agency’s inspections revealed a wide range of issues at the facilities, such as adulterated products and the lack of a quality unit. Read More
The FDA announced that it will take enforcement action against compounders using the unapproved bulk substance cesium chloride, partially granting a December 2017 petition by Public Citizen. Read More
CDER Director Janet Woodcock announced details of two new voluntary programs designed to support improvements in product and process quality and to enhance the agency’s use of quality metrics. Read More
In the wake of hundreds of healthcare fraud arrests by the Justice Department last week, FDA Commissioner Scott Gottlieb promised more inspections of compounding and outsourcing facilities that distribute products without a valid medical need. Read More
The FDA hit Eau Zone Huiles Et Fragrances with a Form 483 after an inspection determined the OTC manufacturer had numerous deficiencies at its Montreal, Quebec facility including cleaning, testing and drug storage issues. Read More