Regulatory Authority Actions

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Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.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CDER withdraws some outdated guidance documents and makes plans to finalize others.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.

EMA?s revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

USP appoints regulatory experts to elemental impurities implementation advisory group.

FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.

FDA Discovers Microbial Contamination in Compound Pharmacy Products

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.