Above The Law

MARCH 11, 2025

Green Steel Technologies Innovations in steel production that reduce carbon emissions, making manufacturing more sustainable. Some innovations, particularly in sustainability and healthcare, may now face regulatory or commercial hurdles before they reach widespread adoption.

Legal 114

Legal Legal Technology eDiscovery 114

Mondaq

DECEMBER 9, 2021

Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals' relationships with pharmaceutical and medical device manufacturers.

Manufacturing 40

Manufacturing Healthcare 40

FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

Manufacturing 59

Manufacturing Contract Laws Statute 59

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The first scenario is a healthcare facility using a medical device 3D-printing production system. use in education, construction, art, and jewelry).

Healthcare 75

Healthcare Manufacturing Drafting Construction 75

JURIST

NOVEMBER 7, 2023

This is not the first suit the government has filed related to pharmaceutical distributors’, manufacturers’ and pharmacies’ role in the opioid epidemic. Cencora has denied the allegations. Johnson & Johnson and Mallinckrodt.

Statute 221

Statute Manufacturing Government Court 221

The Crime Report

JUNE 21, 2021

Goldstein was prescribing Subsys, a potent fentanyl-based spray, in exchange for bribes and kickbacks from Subsys’s manufacturer, according to the United States Attorney’s Office for the Southern District of New York. Clandestinely-produced fentanyl is primarily manufactured in Mexico. But additional profits lay elsewhere.

Manufacturing 145

Manufacturing Court Education Attorney 145

LawTechnologyToday

DECEMBER 10, 2020

If incidents like these can cause the fall of multinational companies, imagine what may happen for smaller manufacturers. When a device manufacturer notices problems with equipment, they go for removal or correction, depending on the prevailing circumstances. If a manufacturer recalls a product, it means it has violated FDA law.

Manufacturing 77

Manufacturing Healthcare Technology Legal 77

The Fashion Law

AUGUST 11, 2021

In response to COVID-19, Burberry donated more than 100,000 pieces of PPE to the NHS and healthcare charities. Meanwhile, LVMH used its perfume manufacturing facilities to make free hand sanitizer for the healthcare system in France.

Healthcare 143

Healthcare Manufacturing Laws 143

Intelligize Blog

MAY 2, 2024

CareDx Healthcare company CareDx , which provides a variety of services to support transplant doctors and patients, discussed the ban in the risk factors section of an April 30 filing. DaVita Another healthcare company, Colorado-based DaVita Inc. , We used the Intelligize platform to identify recent issuer disclosures on this matter.

Healthcare 113

Healthcare Contract Manufacturing Lawyers 113

FDA Law Blog

JUNE 15, 2022

Dara will be joining an expert panel as part of the Medical Affairs and Scientific Communications Track to discuss manufacturer communications related to Healthcare Economic Information (HCEI) and engaging with payers and formulary decisionmakers as part of Pre-Approval Information Exchange (PIE).

Healthcare 40

Healthcare Manufacturing 40

FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

Manufacturing 72

Manufacturing Healthcare Contract Government 72

Law 360

AUGUST 30, 2024

Generic flea and tick medication manufacturer Tevra's evolving market definition played a key role in the development and outcome of its five-year antitrust litigation against Bayer Healthcare, highlighting challenges that litigants may face when a proposed definition is assessed at trial, say Amy Vegari and Colleen Anderson at Patterson Belknap.

Healthcare 52

Healthcare Manufacturing Litigation Litigating 52

LawTechnologyToday

SEPTEMBER 29, 2021

Proving that a healthcare professional made a mistake can be a difficult proposition. However, as the technology has advanced, it is now also used in the early stages of manufacturing. The healthcare professional must owe a duty of care to the injured person, by nature of establishing a doctor/patient relationship.

Healthcare 77

Healthcare Technology Manufacturing Personal Injury 77

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing 81

Manufacturing Healthcare Drafting Legal 81

Above The Law

MAY 10, 2021

The application comes amid calls for all vaccine companies to waive patent protections on these products so that others will be able to manufacture them. The messenger RNA vaccine developed by Pfizer and BioNTech has been formally submitted for FDA approval.

Manufacturing 98

Manufacturing Healthcare 98

Above The Law

OCTOBER 20, 2021

Boehringer Ingelheim has shown biosimilar manufacturers the way to win interchangeability with the world’s highest-grossing drug — but the company’s Cyltezo won't come out until July 2023. Will future Humira competitors have better luck winning an earlier launch date?

Manufacturing 98

Manufacturing Healthcare 98

FDA Law Blog

JUNE 24, 2024

The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical manufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development. will delve into the specifics of the new and improved Format v5.0.

Healthcare 52

Healthcare Manufacturing Education 52

FDA Law Blog

OCTOBER 3, 2022

Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have aggressively pursued antikickback cases in the healthcare industry. Today, these two documents are key in navigating speaker programs in the industry.

Healthcare 105

Healthcare Statute Manufacturing Government 105

Above The Law

NOVEMBER 12, 2021

The company expanded a recall of its at-home COVID-19 tests due to a manufacturing error. The FDA upped the recall to a Class 1 recall, its most serious level, after noting a higher-than-acceptable false positive rate for the affected tests.

Manufacturing 98

Manufacturing Healthcare 98

FDA Law Blog

NOVEMBER 29, 2023

Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change. The evidence used to measure the device’s performance should be scientifically and clinically justified, consistent with the level of risk for the proposed change.

Drafting 115

Drafting Data Management Manufacturing Healthcare 115

SCOTUSBlog

JUNE 11, 2021

Lastly, Healthcare Distribution Alliance v. New York passed a law imposing an annual surcharge on opioid manufacturers and distributors. These and other petitions of the week are below: Healthcare Distribution Alliance v. The state uses the money to pay for remedial programs related to opioid abuse.

Healthcare 107

Healthcare Attorney Manufacturing Statute 107

Patently O

MARCH 4, 2024

For several years, Celanese kept its Ace-K manufacturing process a trade secret while selling the Ace-K product it produced. Historically, an inventor could choose to protect a new manufacturing process either by patenting it or by keeping it as a trade secret – but not both. Celanese appealed. Compare D.L. Auld Company v.

Manufacturing 40

Manufacturing Statute Healthcare Court 40

The Process Street

NOVEMBER 28, 2023

Applications of AI in healthcare Artificial intelligence in the healthcare industry has numerous applications that can improve patient care, diagnoses, and overall efficiency in the industry. And, while Google has led the way for a number of years , the power of machine learning is available to businesses of any size.

Virtual Assistant 105

Virtual Assistant Healthcare Entertainment Education 105

LawSites

APRIL 19, 2023

The company says it experienced dramatic growth last year, tripling its revenue for the third year in a row and expanding its customer base to include hundreds of corporate clients from various industries, including B2B technology, healthcare, consumer goods, manufacturing, and gaming. ”

Technology 81

Technology Contract Healthcare Manufacturing 81

Mondaq

MARCH 2, 2022

Here are last week's curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators' decisions are having an impact across the US.

Manufacturing 40

Manufacturing Healthcare 40

FDA Law Blog

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Whether the Beneficiary Inducement Statute (BIS) is relevant to interpreting the AKS (essentially, no). Background. The Lesson of this Case.

Statute 98

Statute Mens Rea Manufacturing Court 98

FDA Law Blog

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background.

Mens Rea 83

Mens Rea Statute Healthcare Manufacturing 83

Mondaq

FEBRUARY 15, 2022

Software, core of technological innovations, is considered to be the driving force with respect to current developments across sectors such as automobile, healthcare, manufacturing, networking, telecom, etc.

Healthcare 40

Healthcare Manufacturing Technology 40

FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCF : LDT, unmet need within an integrated healthcare system. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule.

Manufacturing 64

Manufacturing Healthcare Education 64

The Crime Report

MAY 27, 2022

Arming teachers is a terrible idea that only makes sense if you are a gun manufacturer or retailer looking for windfall profits. We also need stronger partnerships between schools, families, community institutions, and healthcare providers. Deadly Accidents.

Manufacturing 29

Manufacturing Healthcare Education Technology 29

Patently O

JULY 17, 2022

Instead, a generic manufacturer can sell its product with a “skinny label” that “carves out” any patented uses found in the brand drug’s labeling—and thereby avoid inducing infringement of the brand manufacturer’s patent rights. Caraco (2012). See 21 U.S.C. § 355(j)(2)(A)(viii). c)(2)(i)(O)(2), (c)(2)(i)(P)(2).

Manufacturing 60

Manufacturing Healthcare Court Statute 60

FDA Law Blog

APRIL 4, 2023

By Philip Won — South Korea has made significant achievements over the years in the biohealth industry, establishing the world’s second-largest biopharmaceutical manufacturing capacity. South Korea continues to drive the effort in the biohealth industry, which will lead to more Korean players in the U.S.

Healthcare 52

Healthcare Manufacturing Technology Government 52

Patently O

MAY 16, 2022

We are still waiting for a Gov’t brief in the pending eligibility case of American Axle & Manufacturing, Inc. Top six pending cases: Eligibility : American Axle & Manufacturing v. Accord Healthcare Inc. Neapco Holdings LLC. The court requested the CVSG brief on May 3, 2021–more than a year ago. Spireon, Inc.

Laws 58

Laws Court Manufacturing Healthcare 58

FDA Law Blog

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. This proposed rule is a long-time coming. After Congress failed to enact VALID in December 2022, as part of user fee reauthorization, CDRH declared its intention to promulgate LDT regulations.

Manufacturing 59

Manufacturing Healthcare 59

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Education Small Business Calendaring 64

FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

Manufacturing 45

Manufacturing Calendaring Healthcare Statute 45

FDA Law Blog

OCTOBER 14, 2021

Given these onerous requirements, it is not a surprise that RAS device manufacturers have not sought clearance for RAS devices for oncology procedures. It would also be beyond the scope of what RAS device manufacturers are intending to offer, which is a better surgical tool, not a therapeutic for cancer.

Healthcare 52

Healthcare Manufacturing Construction Legal 52