Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Ropes & Gray LLP ordered by Published Date Descending.
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Non-Binding Guidance: Real-World Evidence In Drug Development And FDA Submissions
The fourth installment of Ropes & Gray's podcast series, Non-binding Guidance, dives into the use of real-world evidence in drug development
United States
15 Aug 2019
What OIG Self-Disclosure Guidance Means For HHS Grantees
This article by counsel Valerie Bonham and partners Kirsten Mayer and Mark Barnes was published by Law360 on August 8, 2019.
United States
14 Aug 2019
FDA CBD Roundup: Agency Continues Existing Enforcement Approach While Reviewing Public Comments And Considering Future Policy Approaches
On May 31, 2019, the U.S. Food and Drug Administration ("FDA") held a much-anticipated public hearing regarding "Scientific Data and Information
United States
12 Aug 2019
CMS Releases Proposed Rules On PFS, QPP And Price Transparency
On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) issued two significant proposed rules: (a) a Proposed Rule that addresses changes to the Physician Fee Schedule
United States
9 Aug 2019
HHS OIG Issues Self-Disclosure Program Guidance For Research Grants And Contracts
Universities, academic medical centers, companies and other recipients and sub-recipients of federal biomedical and basic research funds are under increased scrutiny and facing stiffer
United States
30 Jul 2019
CMS Proposes New Payment Models For Radiation Oncology And End Stage Renal Disease (ESRD)
On July 10, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would implement and test two new mandatory payment models under its Center for Medicare & Medicaid Innovation
United States
29 Jul 2019
NIH Issues New Guidance On "Other Support" And "Foreign Components" In Funded Research
In the wake of ongoing concerns expressed about "foreign influence" in U.S.-funded research activities, the National Institutes of Health (NIH) last week released
United States
24 Jul 2019
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
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
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
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
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
26 Jun 2019
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
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
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
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
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.
30 May 2019
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
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
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
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