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To Recall or Not to Recall? FDA Issues Q&A Guidance on Food Recalls
  • Morgan Lewis
  • USA
  • November 9 2018

On November 6, the US Food and Drug Administration (FDA) announced that its final guidance on Questions and Answers Regarding Mandatory Food Recalls:


OIG Report on Topical Compounded Drug Prescribing, Marketing and Billing Practices Signals Heightened Administrative and Enforcement Scrutiny
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • November 2 2018

When commercially available medications’ standard dosage forms or amounts don’t quite fit a patient’s particular needs, the patient may benefit from


ML Strategies Health Care Lame Duck Preview
  • Mintz
  • USA
  • November 2 2018

With the opioid bill passed, the House on recess and the Senate having cut a deal to get out the door, we all begin to wonder: after the dust settles


Key Takeaways from Newly Signed Bill Aimed to Combat Opioid Crisis
  • Quarles & Brady LLP
  • USA
  • October 29 2018

On October 24, 2018, President Donald Trump signed into law a massive bill intended to combat the opioid crisis. The bill's passage comes a year after


Fall 2018 Agency Rule List & FDA Device Center Guidance Priorities
  • Mintz
  • USA
  • October 24 2018

On October 17th, the Administration released its semiannual forecast of the rules that the Department of Health and Human Services (HHS) will be


FDA & DHS Coordinate Efforts to Address Cybersecurity
  • Knobbe Martens
  • USA
  • October 24 2018

The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership


BakerHostetler FDA and Pharmacy Weekly Digest
  • Baker & Hostetler LLP
  • USA
  • October 23 2018

Last week Health and Human Services (HHS) released its Statement of Regulatory Priorities for Fiscal Year 2019. Several of the FY19 priorities


Cannabis - from Mystery to Medical IP
  • Bereskin & Parr LLP
  • USA
  • October 19 2018

Cannabis still maintains much of its mystery, thousands of years after it was first used by humans. There is great uncertainty among modern medical


Trump Administration Highlights Regulatory and Deregulatory Priorities for HHS
  • Reed Smith LLP
  • USA
  • October 18 2018

As part of the Trump Administration’s fall regulatory agenda, the Department of Health and Human Services (HHS) emphasizes its commitment to “reducing


Federal Health Fraud Penalties Are Rising Once Again
  • Reed Smith LLP
  • USA
  • October 11 2018

The Department of Health and Human Services (HHS) has just announced annual inflation-related increases to civil monetary penalties (CMPs) in its