Regulatory Oversight and Compliance

A review of this year's crop of the new molecular entities and new biologics license applications approved by FDA thus far in 2013.

Baxter has issued a voluntary recall of one lot of nitroglycerin in 5% dextrose injection after particulate matter was found in one vial.

Mylan and the Indian biopharmaceutical company Biocon receive approval for a biosimilar version of trastuzumab in India. Also, Mylan and Teva reach settlement on Copaxone in the EU.

European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.

An operational-excellence initiative increased collaboration between operations and quality personnel to address human-error-caused deviations.

Includes a new approach on developing antibacterial agents targeted against multidrug-resistant (MDR) pathogens where patients have very limited or no remaining treatment options.

FDA releases guidance on pulmonary tuberculosis drugs.

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

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

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.

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.

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

FDA publishes guidance on ANDA submissions.

EMA revises HIV treatment guideline.

Boehringer Ingelheim initiates a recall due to the potential for extrinsic foreign particles in the API used to manufacture Spiriva Handihaler (tiotropium bromide inhalation powder) capsules.

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 import alert due to cGMP violations at Ranbaxy's facility in Mohali, India.

FDA reports that Hospira initiated on July 12, 2013 a voluntary recall of certain lots of bupivacaine HCl due to particulates floating and/or in the glass vial.

FDA updates guidance to reflect advances in technology.