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OTC Drug User Facility Fees Due Soon – Don't Be Late! | Wiley Rein LLP

Originally published on December 30, 2020, this article was last updated on January 6, 2021. On January 4, 2021, FDA unexpectedly withdrew the notice entitled Fee Rates Under the Over the Counter Monograph User Fee Program for Fiscal Year 2021 stating that it had been ordered to cease further collection efforts pending approval from the Secretary of the Department of Health and Human Services (HHS). The withdrawal notice states that the original notice issued without such Secretarial approval...
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Roll call: Keep up with key votes in Congress

House votes Disaster preparedness contracts: The House has passed the Federal Advance Contracts Enhancement Act (S. 979), sponsored by Sen. Marco Rubio, R-Fla., to require the Federal Emergency Management Agency to submit information to Congress and make changes to advance contracts it agrees to for stockpiling goods and planning for services that will be needed in future disaster recovery efforts. A supporter, Rep. Rodney Davis, R-Ill., said the bill’s “reforms will help improve our ...
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MDRP: CMS Final Rule on value-based purchasing, line extension definition, PBM accumulator programs | Hogan Lovells

On December 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule ( link) that materially modifies current Medicaid Drug Rebate Program (MDRP) regulations, largely finalizing the proposed rule dated June 17, 2020 ( link). The Final Rule will be effective on March 1, 2021, 60 days after publication in the Federal Register, which is scheduled for December 31, 2020. Effectiveness after January 20, 2021 (inauguration) means that the Final Rule will likely be subject to th...
Drug Administration Best Price Average Manufacturer Price Final Rule Substance Use Disorder Prevention That Promotes Opioid Recovery

President Trump signs stopgap spending bill to keep government open until Dec. 28

President Trump signs stopgap spending bill to keep government open until Dec. 28 From CNN’s Daniel Allman and Manu Raju US President Donald Trump gives a thumbs up as he departs on the South Lawn of the White House, on December 12. Al Drago/Getty Images US President Donald Trump signed a stopgap spending bill to keep the government open until December 28. Just after midnight, Trump signed the bill, H.R. 1520, known as the “Further Extension of Continuing Appropriations Act, 2021,” which ...
United States White House District Of Columbia Donald Trump Mike Lee Jeremy Herb
Source: cnn.com

Trump Signs $1.4Trln Spending Package That Includes $900Bln in COVID-19 Relief

Trump Signs $1.4Trln Spending Package That Includes $900Bln in COVID-19 Relief © REUTERS / MICAH GREEN Subscribe Sputnik International https://sputniknews.com/us/202012221081540741-trump-signs-14trln-spending-package-that-includes-900bln-in-covid-19-relief/ WASHINGTON (Sputnik) - US President Donald Trump has signed a bill on Tuesday extending budget for six days follow the passage of a $1.4 trillion federal spending package for 2021 by The US House ...
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A Breakdown of the $900 Billion US COVID-19 Relief Package

A Breakdown of the $900 Billion US COVID-19 Relief Package © REUTERS / CARLO ALLEGRI Subscribe Sputnik International https://sputniknews.com/us/202012211081523358-a-breakdown-of-the-900-billion-us-covid-19-relief-package/ US congressional leaders announced on 20 December they had finally agreed on a new coronavirus relief bill which was previously bogged down in protracted negotiations, with both chambers of Congress initially passing a stopgap measu...
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Oregon Hemp: ODA Withdraws Hemp Plan Submitted To USDA - Cannabis & Hemp

To print this article, all you need is to be registered or login on Mondaq.com. The Agriculture Improvement Act of 2018 (2018 Farm Bill) removed hemp and its derivatives from the definition of marijuana under the Controlled Substances Act (CSA) and provided a detailed framework for the cultivation of hemp. The 2018 Farm Bill also gave the US Department of Agriculture (USDA) regulatory authority over hemp cultivation at the federal level, although states have the option t...
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Source: mondaq.com

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