Regulatory Authority Actions

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FDA Issues Draft Guidance on Patient Counseling Info for Labeling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Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.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?

New FDA supply chain policies aim to strengthen inspection and oversight processes.

CDER withdraws some outdated guidance documents and makes plans to finalize others.

EMA publishes reflection paper on issues regarding the parenteral administration of coated nanomedicines.

FDA receives adverse event reports related to calcium gluconate infusions.

The guidance describes a risk-based approach to monitoring of clinical trials.

A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

FDA releases FY 2014 generic-drug user fees.

EMA restructures organization.

EMA releases concept paper on development of product-specific guidance on demonstration of bioequivalence.

FDA funds research to further development of innovative generics, while working to address review and approval issues.

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

Europe prepares for inclusion of Croatia in EMA activities.

Programs assist in the fast track of drugs for serious conditions.

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.