Regulatory Oversight and Compliance

FDA inspections reveal possible inaccurate sterility testing.

Video recorded at Validation Week Canada

Prequalification of Sanofi Pasteur?s Menomune vaccine makes it eligible for purchase by United Nations agencies.

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

The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?

Pharma eyes biologics production in Brazil as the government begins to recognize the potential of these drugs.

FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.

Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.

Dr. Reddy's initiates voluntary recall of ranitidine due to microbial contamination.

The last few weeks have seen the media swamped with stories about the rampant bribery clawing the pharmaceutical industry in China.

Agencies collaborate to ensure consistent product quality.

CDER withdraws some outdated guidance documents and makes plans to finalize others.

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.

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

Industry players brace themselves to face challenges as India's new drug-pricing policy kicks in full gear.

Appropriate use of medications promises to improve patient care and curb spending, prompting pharmacists, public health authorities, and manufacturers to promote multiple adherence strategies.

The bio-pharmaceutical business outlook in South Korea remains positive.

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

Depomed, Inc. announced that FDA has accepted for filing a new drug application (NDA) from Mallinckrodt for MNK-795.

The precautionary recall follows manufacturing deficiencies identified at the site in India.

Compounding, tracking legislation moves forward

Brazil offers opportunities and challenges for global pharmaceutical companies.

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

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