Quality/GMPs

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

FDA releases guidance on pulmonary tuberculosis drugs.

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

A study to investigate metacomplex formation in the hetero-association of a multivalent antigen, streptavidin (SA), and a bivalent antibody (Ab) using a composition-gradient multiangle light-scattering (CG-MALS) system consisting of a composition-gradient device, a MALS detector, and a UV/Vis absorption detector.

FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.

An effective supplier-initiated change management process is discussed.

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

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

Using closed systems opens up many new possibilities for how facilities are designed and operated and may also present lower risk to the operation and, ultimately, the product.

BioPharm International speaks with industry experts about challenges faced in managing the cold chain.

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

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

USP is developing and revising distribution standards in response to changes in the global supply chain.

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

The authors discuss how to develop a cost-effective thermally protective packaging system.

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

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

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.

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

By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.

FDA publishes guidance on ANDA submissions.

EMA revises HIV treatment guideline.

AstraZeneca, Bristol-Myers Squibb recall certain lots of of their antidiabetes drug Bydureon (eventide) due to manufacturing records that batches may contain underfilled vials.

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