Regulatory Oversight

EMA and FDA publish joint QbD guidance on design space verification.

New regulation offers patients in Brazil greater access to experimental drugs.

Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.

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

Siegfried Schmitt of PAREXEL discusses regulation requirements for quality systems.

Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.

IBEF and Pharmexcil report the country?s plans for growth and its commitment to lowering the cost of medicines globally.

FDA is seeking a permanent injunction against a dietary supplement manufacturer following the company?s repeated distribution of unapproved drugs and adulterated dietary supplements.

Parameters for steam-sterilization autoclave overkill cycles should be chosen based on process understanding.

Vaporous hydrogen peroxide, nitrogen dioxide, chlorine dioxide, and carbon dioxide technologies can be used in pharmaceutical manufacturing to sterilize or disinfect.

During the ongoing federal government shutdown, FDA activities will be limited to work involving the safety of human life or the protection of property, and activities funded by carryover user fee balances PDUFA, GDUFA, and MDUFA.

The pharmaceutical industry grows despite conflict in the Middle East.

Foreign companies zero in on Myanmar with the hope of securing a foothold in its pharmaceutical market.

FDA publishes guidance on ANDA submissions.

EMA revises HIV treatment guideline.

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

EMA releases details of restructuring.

FDA updates guidance to reflect advances in technology.

Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.

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.

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.