Quality Systems

Breakthrough Therapies Raise Manufacturing Issues

FDA Moves to Curb Drug Shortages

Biotechnology Industry Organization President James Greenwood writes senators in support of Start-up Jobs and Innovation Act.

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.

Novasep?s European manufacturing sites in France and Germany pass FDA audits.

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

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

The European Pharmacopoeia Commission has decided to change its approach on elemental impurities.

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.

The JOBS Act and FDASIA show early signs of accelerating drug development.

A new report details FDA's role and responsibilities in personalized medicine.

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

CDER recommends reclassifying opioid products as Schedule II.

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

The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs.

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.

Budget issues and changing global markets are prompting FDA to revise its growing network of overseas offices.

The pharmaceutical industry grows despite conflict in the Middle East.

Kurt Lumsden, Director Client Services at Perceptive Informatics, a subsidiary of PAREXEL, discusses regulatory requirements for the drug accountability process.

Recent FDA enforcement activity reveals issues with vial-filling, adequacy of QA/QC procedures, particulate matter in inhalation powders and injectables, and drug labeling.

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

The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.

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