Legal & Regulatory

Covid vaccine-capable system can transport products at a controlled temperature between +20°C and -90°C

Merger agreement, approved by both boards, is expected to close before end of year

It marks the first time that two accrediting organizations with deeming authority from CMS have merged

Aim is to combat counterfeiting, expedite product recalls and help brands meet regulatory requirements

Survey results indicate that only 28 percent of the air cargo industry feels well prepared at this point

But volume and price dynamics remain volatile and uncertainty remains

Originally developed by Ajinomoto for peptide synthesis, the technology has been expanded to include oligonucleotide production

Company scaling up manufacturing capacity and anticipates compatibility with its standard distribution channels

Trump administration's plan sounds good but faces severe operational obstacles

One expert's take on the key issues at stake

National Academy of Medicine offers a vaccine allocation ‘framework’; will it be followed?

Generics trade association is confronting a new, post-pandemic era

Little hope for a flurry of executive orders that revive drug importation and rebate transactions in Medicare

Steady progress is occurring in the global effort to track pharmaceutical distribution, even as new technical and business opportunities appear

Robert Wood Johnson Foundation-sponsored study assesses the situation

Position highlights the move toward more at-home services

Industry consortium is poised to manage pharma supply-chain interoperability governance

Quarles & Brady garners an innovative distinction

Strains are showing in drug supplies consumed in treating infected patients

Production quotas for controlled substances are being raised by 15%

Newly initiated trials may prove value—but even then, supplies may be limited, and hoarding is already occurring

DEA-registered practitioners can prescribe without an in-person interview

Guidance enables these workers to continue reporting to work

Now two-plus years on, the dispute over physician databases shows no sign of resolution

Too many states have opted out of the $18-billion agreement being negotiated in federal court

Of NDA/BLA drugs, 45% require cold-chain distribution

Trump administration drops its bombshell proposal to open up the US pharmaceutical market

January meeting will bring patient advocates, industry and regulators together

Partnership for DSCSA Governance, Inc. is up and running

Clears Senate confirmation by a 72-18 vote