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Wiley's 2025 Key Trade Developments Series: Trade Remedies
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(Podcast) The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
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Hot Topics in International Trade A Year in Review (Quickly)
As the audits and investigations of wound care procedures with skin substitutes march on, providers who were audited once by a CMS unified program integrity contractor (UPIC) should prepare for a second round. And if the UPIC...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more
Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more
Legal challenges for innovative cell, tissue, and gene therapies (CTGTs) are mainly seen in the still evolving regulatory environment. However, it is also crucial for the manufacture and supply of CTGTs to have agreements in...more
Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more
The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more
For the first time in almost 10 years, the U.S. Food and Drug Administration (FDA) released a draft guidance related to certain communications by firms to healthcare providers (HCPs) of scientific information on unapproved...more
On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
For good reasons, including product safety, quality assurance, development of delivery procedures and instructions, it has been a common practice for medical device companies and innovators to consult with physicians during...more
The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more
The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” which details the...more
On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical devices and 21 CFR § 201.128 for drugs. This updated final...more
On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more
Effective August 13, 2020, an Interim Rule jointly issued by the Department of Defense (DoD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) that amends the Federal...more
Rösler expands AM Solutions division to offer 3D printing services - AM Solutions, the Italian 3D printing subsidiary of the Rösler Group, a German company specializing in surface finishing solutions, will expand to offer a...more
On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical Device Cybersecurity" (IMDRF...more
The U.S. Food and Drug Administration took the unprecedented step this week of issuing an alert to health care providers and device manufacturers about potentially serious security flaws that may allow hackers to remotely...more
Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more
Pharmaceutical outsourcing has emerged as a robust—and rapidly growing—subsector of the life sciences industry. As the push for efficiency continues, more pharmaceutical, biotech and medtech companies are turning to contract...more
After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration yanked from the market a surgical mesh widely used to repair pelvic conditions in women....more
Late last year, the Food and Drug Administration’s (FDA’s) Device Center announced a new objective when it comes to devices – “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and...more