Quality/GMPs

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

By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.

FDA publishes guidance on ANDA submissions.

EMA revises HIV treatment guideline.

AstraZeneca, Bristol-Myers Squibb recall certain lots of of their antidiabetes drug Bydureon (eventide) due to manufacturing records that batches may contain underfilled vials.

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FDA Issues Draft Guidance on Patient Counseling Info for Labeling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Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.

Video with Paul Pluta

Updates on user fees, heparin supply concerns, orphan drug incentives, REMS updates, reference standards for proteins, and patent settlements.

Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.

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CDER withdraws some outdated guidance documents and makes plans to finalize others.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

The authors discuss the application of risk management in process lifecycle validation, manufacturing, and change control.