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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Ropes & Gray LLP ordered by Published Date Descending.
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1
A Guide To FCA Cooperation Credit For Life Sciences Companies
On May 7, 2019, the U.S. Department of Justice issued guidelines describing when and under what circumstances it will award cooperation credit in False Claims Act matters.
United States
9 Jul 2019
2
New York's Highest Court Holds That Medical Practices That Cede Too Much Control To MSOs Are "Fraudulently Incorporated" And Ineligible To Be Reimbursed By No-Fault Automobile Insurers
On June 11, 2019, the New York Court of Appeals (the "Court")—the highest court in New York State—issued a rare opinion on the State's broad corporate practice of medicine prohibition
United States
5 Jul 2019
3
Podcast: Non-Binding Guidance: Examining FDA's Enforcement Authority Over Stem Cell Clinics And Compounders
The third installment of Ropes & Gray's podcast series, Non-binding Guidance, highlights two recent federal district court decisions implicating enforcement efforts in the stem cell and compounding arenas.
United States
4 Jul 2019
4
Trending Video: Drug Pricing Initiatives During The Trump Presidency (Video)
Tom Bulleit, Ropes & Gray health care partner, discusses the Trump Administration's latest drug pricing initiatives.
United States
28 Jun 2019
5
China's State Council Publishes New Regulations On The Management Of Human Genetic Resources
China's State Council, the country's top administrative authority, released a new Regulation of Human Genetic Resources1 (the "Regulation") on May 28, 2019, to replace the tentative rules issued
China
26 Jun 2019
6
What's New For CMS Bundled Payments Program
On April 24, 2019, the Centers for Medicare & Medicaid Services released a request for applications for the Bundled Payments for Care Improvement Advanced model for its second cohort
United States
19 Jun 2019
7
Supreme Court Clarifies That Judges, Not Juries, Must Determine Whether FDA Actions Preempt State Failure-To-Warn Claims Against Drug Manufacturers
On May 20, 2019, the U.S. Supreme Court ruled in Merck Sharpe & Dohme Corp. v. Albrecht that, in analyzing whether a state law failure-to-warn claim against a drug manufacturer is preempted by federal
United States
11 Jun 2019
8
FDA Issues Final Guidance On "Considerations In Demonstrating Interchangeability With A Reference Product"
On May 10, 2019, the Food and Drug Administration (FDA) issued final guidance on "Considerations in Demonstrating Interchangeability With a Reference Product," which describes the agency's
United States
6 Jun 2019
9
CMS Announces Request For Applications: BPCI Advanced Model Year 3
On April 24, 2019, the Centers for Medicare and Medicaid ("CMS") released a Request for Applications ("RFA") for the Bundled Payments for Care Improvement Advanced Model ("BPCI Advanced") for its second cohort of applicants since the program's inception.
United States
6 Jun 2019
10
China Proposes Major Changes To Pharmaceutical Regulations
On April 20, 2019, the Chinese government submitted a second draft of the Drug Administration Law of the People's Republic of China to the Standing Committee of the NPC for deliberation.
China
30 May 2019
11
What To Know About The CMS Primary Cares Initiative
On April 22, 2019, the U.S. Department of Health and Human Services and its Centers for Medicare & Medicaid Services (CMS) announced the "CMS Primary Cares Initiative,"
United States
27 May 2019
12
New FDA Draft Guidance On Voluntary Recalls Asks: Are You Prepared?
On April 24, 2019, the Food and Drug Administration ("FDA") released a draft guidance, entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,"
United States
21 May 2019
13
Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb's Unfinished Business
Tune in to this discussion to learn more about the unfinished business of the Gottlieb administration, the impact of his resignation, and how the agency will move forward under Acting Commissioner Ned Sharpless.
United States
8 May 2019
14
India Finalizes Rules Regarding Compensation For Subjects Injured In Clinical Trials And Post-Trial Access To Study Drugs
Since 2013, India's clinical trials regulatory framework has undergone continuous, significant changes to bolster protections for clinical trial participants.
United States
7 May 2019
15
Senators Ask HHS To Step Up Scrutiny Of Pods Under Sunshine Act
On March 19, 2019, Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR) of the Senate Finance Committee ("SFC") wrote a letter (the "POD Letter") to the HHS Office of Inspector General ("OIG")
United States
3 May 2019
16
Podcast: Non-Binding Guidance: FDA's Regulation Of Products Containing CBD
Ropes & Gray's new podcast series, Non-binding Guidance, highlights FDA regulatory developments and trends affecting the life sciences industry.
United States
2 Apr 2019
17
New International Pharmaceutical Practice Code Tightens Restrictions On Gifts
On January 1, 2019, the revised Code of Practice issued by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) went into effect.
United States
7 Mar 2019
18
HHS Sets Out To Tackle Health Information Access And Exchanges
On Feb. 11, 2019, two agencies of the U.S. Department of Health and Human Services coordinated the release of complementary proposed rules designed to support and advance seamless and secure access...
United States
5 Mar 2019
19
In Coordinated Proposed Rules, ONC And CMS Seek To Tackle Interoperability, Information Blocking, And Patient Access To Health Information
On February 11, 2019, two agencies of the U.S. Department of HHS coordinated the release of complementary proposed rules designed to support and advance seamless and secure access, exchange, and use of EHI.
United States
28 Feb 2019
20
Transcending Traditional Health Care: A Growing Trend At HHS Embracing A Broader Vision Of Health Care
In the past few weeks, divisions of the U.S. Department of Health and Human Services ("HHS") have taken three separate actions that, while individually distinct, collectively reflect
United States
19 Feb 2019
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