Searching Content indexed under Food and Drugs Law by Ropes & Gray LLP ordered by Published Date Descending.
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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
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
New FDA Draft Guidance On Voluntary Recalls Asks: Are You Prepared?
On April 24, 2019, the Food and Drug Administration ("FDA") released a draft guidance, entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,"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
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
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
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
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
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
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
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
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
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
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
CMS Issues Proposed Rule To Require Disclosure Of List Price In Direct-To-Consumer Advertising For Prescription Drugs And Biological Products
Allow the Department of Health & Human Services to maintain a public list of drugs and biological products advertised in violation of the rule.
United States
24 Oct 2018
China's Health Authorities Issue New Rules on Telemedicine
The Measures clarify longstanding ambiguities regarding the scope of permitted telemedicine.
26 Sep 2018
China's New Medical Device Regulations Bring Big Changes
The current MDR requires medtech companies to either conduct clinical studies in China or submit clinical evaluation reports illustrating equivalence to previously approved products
31 Jul 2018
FDA Clarifies Communication Rules For Medical Product Companies
On June 12, 2018, the U.S. Food and Drug Administration issued two key documents outlining the agency's current thinking regarding drug and device manufacturers' communication of information not contained in product labeling.
United States
25 Jun 2018
FDA Issues Final Guidance Documents Relating To Medical Product Manufacturer Communications
The changes to the guidance documents are extensive, but generally provide additional flexibility for manufacturers to convey certain types of product information.
United States
18 Jun 2018
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