Regulatory/GMP Compliance

Baxter International recalls dextrose injection and four sodium chloride injections.

NPS Pharmaceuticals uses its expertise in development, regulatory compliance, and commercialization to bring to market products with orphan drug status.

FDA details efforts to evaluate potential risks from use of nanomaterials in drug products and discuss analytical considerations, impact on stability, safety, and toxicology effects.

The international “Fight the Fakes” campaign will raise awareness about the dangers of counterfeit medicines.

USP issues call for candidates for its 2015-2020 Council of Experts.

Using closed systems opens up many new possibilities for how facilities are designed and operated and may also present lower risk to the operation and, ultimately, the product.

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

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.

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

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

FDA Issues Draft Guidance on Patient Counseling Info for Labeling

FDA updates guidance to reflect advances in technology.

Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.

Video with Paul Pluta

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CDER withdraws some outdated guidance documents and makes plans to finalize others.

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

Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.

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