Articles related to FDA & Life Sciences

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GLP-1 Gold Rush Meets Legal Reality: Novo Nordisk Challenges Compounded Alternatives

[03/05/26]

A Turning Point for OPDP: What 2025 Enforcement Activity Signals for 2026

[12/22/25]

Enforcement Marches on: OPDP Issues Third Untitled Letter of 2025 Amid Staffing Shake-Ups

[05/23/25]

Texas District Court Strikes Down FDA’s Laboratory Developed Tests Final Rule Less Than Two Months before Phase I Implementation

[04/28/25]

The Calm Before the Storm: OPDP Released Two Untitled Letters Before HHS’s Reduction in Force, Now What?

[04/17/25]

FDA Issues Final Guidance on Communications About Unapproved Uses of Medical Products

[01/30/25]

A “Healthier” Future? FDA Updates “Healthy” Labeling Criteria

[01/14/25]

Five OPDP Letters in 2024: Trend or Coincidence?

[12/06/24]

DSCSA Update – FDA Extends Deadline for Connected Trading Partners to Meet Requirements

[10/18/24]

From an Instagram Post to a Television Commercial, OPDP Issues Its Fourth Untitled Letter of 2024

[10/16/24]

Summer Is Heating Up with Two New OPDP Untitled Letters

[08/22/24]

A Year Later—Revisiting FTC’s Updated Endorsement Guides

[07/17/24]

NAD Recommends that Medical Device Manufacturer Discontinue Advertising Claims Following Competitor Challenge

[07/11/24]

FDA Issues Revised Guidance on the Promotion and Advertising of Biologics

[07/08/24]

Remanufacturing or Servicing of Medical Devices: FDA Issues Final Guidance Providing Additional Clarification

[06/21/24]

U.S. Supreme Court Issues Ruling Rejecting Challenge to Mifepristone Access

[06/18/24]

From Discretion to Regulation: What FDA’s Final Rule Means for Laboratory Developed Tests

[06/05/24]

Data Monitoring Committees in Clinical Trials: FDA Draft Guidance Released

[05/22/24]

New Year, New Letter: OPDP Issues Its First Enforcement Letter of 2024

[02/06/24]

Is Five the Magic Number for OPDP Enforcement Letters in 2023?

[12/15/23]

A Whole New World for Laboratory Developed Tests – FDA Proposes End to Its Longstanding Policy of Enforcement Discretion

[11/30/23]

FDA Finalizes Its Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors

[10/05/23]

FDA Outlines Considerations for Conducting Clinical Investigations Using Psychedelic Drugs

[09/15/23]

Embracing Technology: FDA Releases Draft Guidance on Decentralized Clinical Trials

[09/14/23]

FDA Issues Final Guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertising

[09/08/23]

OPDP 2023 Enforcement Heats Up with Two New Letters Issued in the Month of August

[09/06/23]

Federal Court of Appeals Panel Issues Ruling in Litigation Challenging FDA Approval of Mifepristone

[08/31/23]

The Wait Is Over . . .  OPDP Issues Its First Untitled Letter of 2023 

[07/14/23]

U.S. Food and Drug Administration Issues Draft Guidance Updating Good Clinical Practices 

[06/29/23]

A Look Back at the Office of Prescription Drug Promotion Enforcement in 2022 and Lessons for 2023

[03/29/23]

Important Information for COVID-19 Vaccine Providers

[12/15/20]

Seeking Solutions for Scarce Resources: Options to Boost Medical Supplies and Devices to Battle COVID-19

[03/26/20]

FDA Issues Guidance on COVID-19 Disruptions to Clinical Trials

[03/19/20]

FDA Revisits Unsubstantiated Claims Surrounding Pharmacogenetic Testing

[02/26/20]

Novel Coronavirus 2019-nCoV and FDA’s Emergency Use Authorization Authority

[02/26/20]

DOJ Probe of Pharmaceutical Companies Implicates Patient Assistance Programs

[12/10/19]

Homeopathic Products Manufacturers Beware – FDA Steps Up Plans for New Enforcement Regime

[10/25/19]

What’s in YOUR Cannabidiol Product Claim? FDA and FTC Want to Know

[10/24/19]

The Practice of Medicine vs. Protecting Patient Safety: Groundbreaking Court Ruling in Support of the FDA’s Regulation of Certain Stem Cell Therapies

[06/11/19]

Discount Disruption: PBM Rebate Protection May Be Removed, New Safe Harbors Combat Increasing Drug Costs

[02/01/19]

FDA Clarifies Position on CBD After Passage of 2018 Farm Bill

[01/18/19]

Department of Homeland Security and FDA Collaborate to Address Medical Device Cybersecurity

[11/02/18]

Delay of “2018 Requirements” that Revise the Common Rule

[04/04/18]

Final FDA Guidance on Interoperable Medical Devices

[09/20/17]

New Guidance: FDA Allows Waiver of Informed Consent for Minimal Risk Research

[08/22/17]

HHS Finalizes Major Updates to Regulations for Protection of Human Research Subjects

[01/19/17]

FDA Releases Final Post-Market Guidance on Medical Device Cybersecurity

[01/11/17]

FDA Finalizes Guidance on Medical Device Data Systems

[02/10/15]

FDA Issues Guidance for Cybersecurity in Medical Devices

[10/09/14]

A Balancing Act: Pending Legislation Seeks to Improve Prescription Drug Access While Curbing Abuse

[08/04/14]

FDA Publishes Compounding Guidance, but Where Are the Regulations?

[08/01/14]

Face to Face Is Changing for the Better – CMS Publishes Home Health PPS 2014 Proposed Rule

[07/11/14]

FDA Will Stop Enforcing Regulatory Requirements for Many Medical Image and Data Systems

[07/11/14]

Implications of the U.S. District Court Opinion Vacating the 340B Program’s “Orphan Drug” Final Rule and Regulations

[05/29/14]

FDA, ONC and FCC Issue Long-Awaited Recommendations for Regulation of Health IT

[04/10/14]

FDASIA Report Tasks FDA with Clarifying Its Approach to Health IT

[04/10/14]

MedPAC Recommends Decreasing Payments for Hospital Outpatient Services

[02/06/14]

Bipartisan Stark Law Corrections Bill Introduced with Assistance from Hall Render Attorneys

[12/19/13]

President Signs Compounding Pharmacy Bill – First Related FDA Guidance Published

[12/04/13]

President Signs Compounding Pharmacy Bill – First Related FDA Guidance Published

[12/01/13]

The Drug Quality and Security Act: Implications of the Proposed New Law for Compounding Pharmacies and the Pharmaceutical Supply Chain

[11/26/13]

Sunshine Act Compliance Begins: CMS Provides Related Payment Tracking Apps, Q&As and Other Resources

[08/09/13]

OIG Issues Updated Self-Disclosure Protocol

[04/22/13]

Final Sunshine Rule Requires Reporting of Physician Ownership in GPOs and Health Products Manufacturers

[03/13/13]

CMS Publishes the Final Physician Payment Sunshine Rule

[02/20/13]