FDASIA Is Signed, Not That White House Wanted Anyone To Notice
White House sends out short press release as FDA is conducting an unrelated briefing to announce the user fee bill was enacted, surprising stakeholders and generating political questions.
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Medicare Part D Plans To Control Opioid Access With ‘Lock In’ Program
Addiction prevention legislation empowers Medicare drug plans to restrict prescriber, pharmacy access to opioids for ‘at risk’ beneficiaries.
GDUFA Stakeholder Deadline May Come After Negotiations Conclude
Generic drug user fee reauthorization talks remain on schedule and are expected to last about four months.
Rx Companies Push For Exemptions To Breadth Of FDA Inspections
Sterile areas, cell therapies, and security systems are just a few of the items where industry wants FDA inspector access limited without triggering a new law that would make products in a facility deemed adulterated.