Regulatory Authority Actions

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.

FDA publishes guidance on ANDA submissions.

EMA revises HIV treatment guideline.

Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.

EMA releases details of restructuring.

FDA Issues Draft Guidance on Patient Counseling Info for Labeling

FDA updates guidance to reflect advances in technology.

The association representing the research-based pharmaceutical industry in Europe is concerned that an EMA policy will put transparency ahead of public-health interests.

Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.

The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?