administrator

Seindni Co., Ltd. – 533363 – 12/05/2017

CGMP/Finished Pharmaceuticals/Adulterated

Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics

MCMi regulatory science project to research issues that are key to understanding and predicting if—and how—vaccines and therapeutics to prevent…

Center for Drug Evaluation and Research Organization Chart

Organization chart for the FDA’s Center for Drug Evaluation and Research, including leadership roles.

Guidance and Other Information of Special Interest to MCM Stakeholders

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear…

Nissan, SK On announce $661M EV battery supply deal

The automaker will use the batteries for electric vehicles manufactured at its assembly plant in Mississippi.

Guidance Recap Podcast | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

Guidance Recap Podcast: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

EU pushes back retaliatory tariffs on US to mid-April

The decision provides additional time for discussions with the Trump administration, according to a European Commission spokesperson.

De minimis changes: Businesses, trade groups weigh in

Customs and Border Protection proposals to increase data requirements and limit the exemption’s use drew a mixed response from commenters.

FDA to Compounders: Know Your Bulks and Excipients Suppliers

FDA has identified several issues over the past few years related to repackers of bulk drug substances, also called active…

Kroger keeps eye on produce tariff exposure

The supermarket chain is also identifying opportunities to diversify its sourcing base for other commodities.