Regulatory Authority Actions

Industry and regulators seek global system that reduces regional differences.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.

FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.

The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.

Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.

The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.

The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.

The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.

New tools and policies aim to support more complex manufacturing processes.

FDA, Health and Human Services, and the Trump Administration back cheaper foreign drugs to cut pharma costs.

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.

The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.

FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.

The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.

The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.

FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.

The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.

Congress is weighing in on drug pricing with a range of measures that differ in style and substance.

Vida International received an FDA warning letter after an inspection found quality control violations.

The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.

Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.