FDA and the European Medicines Agency on Wednesday (Sept. 15) launched a pilot program through which both agencies will provide parallel scientific advice to generic drug makers who are pursuing marketing approval for their products through FDA’s complex generic pathway or through EMA’s hybrid products path.
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Senate Dems Considering More Generous Medicare Benefits, Earlier Start
The Senate Democratic caucus hopes to add benefits to Medicare that are more generous and kick in sooner than those marked up by House committees -- and the Senate’s emerging plan could be even more generous than Senate Budget Chair Bernie Sanders’ (I-VT) initial proposal, caucus documents indicate.
Latest Pandemic News
Marks Lashes Out At FDA Vaccine Advisers After COVID-19 Booster Vote
Tensions around COVID-19 vaccine booster discussions were on full display Friday (Sept. 17) as FDA’s vaccine advisers voted in favor of authorizing a booster dose of Pfizer’s COVID-19 vaccine for certain populations but overwhelmingly voted against approving the extra shot for people 16 and older, prompting FDA biologics center Director Peter Marks to remind committee members they ultimately do not determine FDA’s final approval decision.
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- Govt. Set To Quickly Roll Out COVID-19 Boosters If FDA, CDC On Board
- Moderna Says New Data Support Need For COVID-19 Booster Shots
- As Biotech Groups Lobby Against IP Waiver, USTR Stays The Course
- Lawmakers, Civil Society Groups Urge Biden To ‘Follow Through’ On IP Waiver
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House Energy & Commerce Chair Frank Pallone recently pledged to work with lawmakers from both parties moving forward to avert physician pay cuts, but the New Jersey Democrat said now’s not the time to act given CMS just received comments on its proposed 2022 fee schedule.
House Speaker Nancy Pelosi (D-CA) plans to keep her promise of holding a Sept. 27 vote on the bipartisan infrastructure bill, but she expects it to fail because it won’t be coupled with reconciliation, and she plans to bring infrastructure back for a second vote in the fall after negotiating a reconciliation deal with the Senate, lobbyists say.
The few applications to CMS innovation center’s third phase of its emergency triage, treat and transport program is likely due to pandemic-related pressure on nursing and not because of a lack of interest, ambulance providers said after the agency withdrew its notice of funding opportunity to set up new ways to triage Medicare beneficiaries calling 911.
CMS should come up with procedures for monitoring temporary changes to home- and community-based services and evaluate the changes made to HCBS programs in response to the COVID-19 public health emergency, the Government Accountability Office recommended in a report released earlier this month.
House Energy & Commerce Committee leaders say they hope to get Cures 2.0 passed by the end of the year so that President Joe Biden’s proposed Advanced Research Projects Agency for Health (ARPA-H) can get up and running as soon as possible.
The House Ways & Means Committee on Wednesday (Sept. 15) passed as part of its reconciliation bill a provision that limits the number of rare disease drugs that can qualify for tax credits under the Orphan Drug Act, despite rare disease organizations’ assertions the provision would disincentivize research and could limit patients’ access to life-saving therapies.
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