Regulatory Oversight and Compliance

Remaining calm, cool, and collected during mergers and inspections is a feat in itself.

The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.

Public-private R&D partnerships are on the rise across Europe, but national goals and academia-industry competition could prevent their success at the European level.

From disagreement to denial, being cordial about quality control can be challenging.

President Obama and HHS eye innovation and countermeasures to protect public health.

The European Medicines Agency and the US Food and Drug Administration announced their individual regulatory decisions and resulting actions regarding the marketing of GlaxoSmithKline's (London) Avandia (rosiglitazone), a thiazolidinedione used to treat Type 2 diabetes.

Amgen (Thousand Oaks, CA) issued a voluntary recall last week of certain lots of Epogen(R) and Procrit(R) (Epoetin alfa) vials.

The US Food and Drug Administration recently issued a Warning Letter to Bristol-Myers Squibb (BMS, New York) for violations of current good manufacturing practice at the company's Manati, Puerto Rico, manufacturing facility.

Weighing the pros and cons of REMS for bringing risky products to market.

A look at why Brazil revised its GMP standards and how the changes will affect the local pharmaceutical industry.

From weekend deliveries to nonsterile gloves, a single exception can make a product fall flat.

India has evolved from a low-cost region to an area with extensive technical capability and high quality standards.

The US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program.

Fallout escalates from McNeil recall and Genzyme shortages as regulators review oversight.

Cases of overlooking proper packaging, reconstitution, directions, and dissolution.

FDA chemistry reviewers in the Office of Generic Drugs provide an overview of common deficiences cited throughout the Chemistry, Manufacturing, and Controls section of ANDAs.

Manufacturers and regulators on both sides of the ocean move to ensure the safety of heparin and other globally distributed drug products.

The recent amendment to Annex 1 has seen controversial changes relating to the capping of vials.

New isolator and disposable technologies are set to assume a greater role in pharma manufacturing, according to a recent conference in Germany.

Changes to Part 2 of the EU GMP guide will come into force by 31 July 2010 in order to bring it in line with the ICH Q9 guideline on Quality Risk Management. As a result, it will no longer be identical to the ICH Q7 guideline on APIs - a harmonised guideline for the US, Europe and Japan.

As generic divisions become the most-wanted acquisitions of Big Pharma, India's domestic industry may be thinning out.

Reports of overlooked controls, dropped pallets, and misplaced documents leave a chill in the air.

More information may be released to improve public understanding of regulatory policies.

The US Food and Drug Administration issued on June 25 a draft guidance for industry, "CMC Postapproval Manufacturing Changes Reportable in Annual Reports," to provide recommendations to drug applicants about the types of changes that may be included in annual reports.

Europe needs a more standardised and consistent approach for supplying excipient information to the regulators.