Legal & Regulatory

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

Helio Health survey sees nagging compliance problems

Global Track & Trace Forum commemorates its 10th anniversary

Change.org touts its influence in the decision

DEA’s manufacturer and distributor data-collection requirements are changing

Sample management is just one of many focus areas for sales operations

Licensing for Gilead’s Truvada and Descovy products is in question

Action expands Pharma Logistics’ leadership in servicing independent pharmacies

Task force report highlights the economic disincentives of short-supply products

New group will coordinate end-to-end supply chain practices in the US

Upstart organization seeks to create another pathway for acceptance by regulators and pharmacy benefit managers

Certification of its Itasca, IL central control tower

Trading partners will have until November 2020 to get their IT systems into operation