Regulatory Authority Actions

EMA's guidance focuses on the use of pharmacogenomics to improve drug safety monitoring.

FDA adds Ranbaxy's Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location

FDA releases guidance on developing drugs for the treatment of community-acquired bacterial pneumonia.

FDA releases guidance on the qualification of drug development tools.

Abrams Royal Pharmacy is recalling all unexpired lots of sterile products dispensed in the US.

Genzyme plans to appeal FDA?s decision that the multiple-sclerosis treatment is not ready for approval.

Baxter International recalls dextrose injection and four sodium chloride injections.

FDA and EMA launch initiative to share bioequivalence inspection information.

Agency issues precautionary recall due to manufacturing fault.

Agency issues precautionary recall due to manufacturing fault.

OGD is under pressure to improve review operations.

EMA revises its polices on fee reductions for orphan drugs for 2014.

Drug Quality and Security Act gives FDA authority over compounding pharmacies.

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.

European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.

FDA releases guidance on pulmonary tuberculosis drugs.

FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.

A new report details FDA's role and responsibilities in personalized medicine.

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.

USP is developing and revising distribution standards in response to changes in the global supply chain.

Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.

FDA is seeking a permanent injunction against a dietary supplement manufacturer following the company?s repeated distribution of unapproved drugs and adulterated dietary supplements.

During the ongoing federal government shutdown, FDA activities will be limited to work involving the safety of human life or the protection of property, and activities funded by carryover user fee balances PDUFA, GDUFA, and MDUFA.

Manufacturing standards are considered key to preventing drug recalls and shortages.