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Set Alert for Manufacturing

Glass-Related Drug Recalls Decline After Industry Improves Practices

The number of sterile drug recalls from glass delamination, breakage and other sources of contamination has dropped dramatically since 2010, with the exception of several spikes in 2013 and 2014. FDA and other officials attribute the drop to better risk assessments and fuller evaluations of product formulations' interactions with container closure systems. The industry is also exploring the use of a new, reportedly sturdier type of glass vial that eliminates delamination.

Manufacturing Quality Recalls

Latest From Manufacturing

CHPA Eyes Spanning Self-Care Space With Bridge To Device Sector

Many CHPA members also market medical devices "and the consumer side of medical devices is something they feel is underrepresented by other trade associations,” says trade group head Scott Melville. OTC drugs already have “a lot in common” with consumer medical devices, including that paying for neither typically is included in health insurance plans.

Consumer Prescription To Otc Switch

Risk-Based Contamination Limits Suggested For Highly Potent Drugs

As more highly potent and highly toxic drugs are being developed, regulators are looking into risks posed by contamination of non-contact surfaces, yet until recently, there was scant guidance on how to assess these risks.

Europe United States

Why Most Firms Still Don't Use RABS Or Isolators To Better Protect Filling Lines From Contamination

Despite the reduced risk of contaminating sterile drug products, most manufacturers are still not using advanced technologies such as RABS and isolators in the cleanroom. High costs and lack of regulatory pressure were cited in survey responses as reasons for the slow uptake. 
United States Manufacturing

Industry Groups Seek Clarity From FDA On Exception Handling Under DSCSA

As supply chain partners drill down into implementing the last phase of Drug Supply Chain Security Act serialization, they ask FDA for more clarity, and some relief, on exception handling for products with no serial numbers after full track-and-trace goes into effect.
Manufacturing Quality

Proposed Legislation Would Help FDA Stop Illicit Opioids At Border -- And More

US FDA would gain more of the ability it seeks to interdict illicit opioids at the border under legislation proposed by House Energy & Commerce Committee's top Democrat. But would there be collateral damage to the legitimate pharmaceutical industry?

Distribution Compliance

Gene Therapy Manufacturing Remains Large Hurdle For Development, US FDA's CBER Director Says

Scale-up in particular is a challenge and FDA wants to help lower the barrier, CBER Director Peter Marks tells rare disease conference.

Regenerative Medicine Research and Development Strategies
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