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Searching Content indexed under Food and Drugs Law by Ropes & Gray LLP ordered by Published Date Descending.
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1
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
2
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
3
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
4
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
5
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
6
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
7
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
8
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
9
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
10
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
11
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
12
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
13
The Trump Administration's Latest Drug Pricing Initiatives
Donald Trump's election in 2016 placed pharmaceutical companies in uncharted territory. Unlike predecessors from both major political parties, Trump did not shy away from directly criticizing the industry.
United States
21 Jan 2019
14
Changes In Federal Regulation Of CBD And Other Hemp Products Will Create New Opportunities For Investment, But Regulatory Challenges Remain
On December 20, 2018, President Trump signed the Agriculture Improvement Act of 2018 (P.L. 115-332), commonly referred to as the "2018 Farm Bill," into law
United States
16 Jan 2019
15
New York Judge Finds $600M Opioid Surcharge Unconstitutional
In December 2018, the U.S. District Court for the Southern District of New York ruled that New York's $600 million fee on the sale of opioids into the state unconstitutionally prohibits pharmaceutical companies from passing the cost onto consumers.
United States
10 Jan 2019
16
Aiming To Foster Innovation, FDA Proposes Regulatory Framework Specific To Prescription Drug Software
As such, the software output would be subject to FDA's regulations for FDA required labeling or promotional labeling, as applicable.
United States
5 Dec 2018
17
Another Step Toward Harmonization: FDA Issues Proposed Rule To Waive Informed Consent Requirements In Minimal-Risk Studies
On November 15, 2018, the U.S. FDA published a proposed rule1 that would allow IRBs to waive or alter informed consent when a clinical investigation poses no more than minimal risk to, and includes appropriate safeguards...
United States
30 Nov 2018
18
HHS Proposes January 1, 2019 Rollout Of The 340B Drug Pricing Program's Civil Monetary Penalties And Clarified Drug Ceiling Price Calculation
On November 2, 2018, the Health Resources and Services Administration of the United States Department of Health and Human Services
United States
29 Nov 2018
19
CMS Outpatient Payment, MA Plan Design, And 340B Rules: Cost-Cutting Trends
These final rules, released for prepublication display on November 1 and 2, reinforce a developing trend away from delivery of care in traditional inpatient care settings.
United States
29 Nov 2018
20
A Closer Look At CMS' Drug Price Disclosure Proposal
One important difference between the standards is how strong the government's interest must be in order to justify the regulation.
United States
29 Oct 2018
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