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).

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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).

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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.

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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).

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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.,

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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.

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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.

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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.

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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.

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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?

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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.

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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.

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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.

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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.

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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.

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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.

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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. ”

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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.

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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.

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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.

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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.

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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.

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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.

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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).

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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.

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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.

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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.

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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?

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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.

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FDA Law Blog

AUGUST 23, 2022

After two negative tests, you should consider a molecular test, or call your healthcare provider. If the third test is negative, you should test again with an antigen test, or get a laboratory molecular-based test, or call your healthcare provider. If the second test is negative, you should test again 48 hours after the second test.

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FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” By Philip Won & Jeffrey K. It applies whether the software is the entire device (i.e.,

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FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”.

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FDA Law Blog

JANUARY 5, 2023

The Playbook is a guide for healthcare delivery organizations to respond to cybersecurity incidents that threaten device function and, potentially, patient safety. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

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Fordham Law News

OCTOBER 18, 2023

The United States spends more on healthcare than any other country.[1] Various drug manufacturers and industry groups have filed lawsuits seeking to halt the Program.[9] 12] Manufacturers also worry about the effect Medicare’s public pricing could have on private sector profits. 3] On average, prescription drug prices are 2.56

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FDA Law Blog

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? There appears to be significant overlap in content between the Checklist and informed consent forms and processes routinely provided by healthcare providers to their patients. What is going on here? Draft Guidance.

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FDA Law Blog

JUNE 22, 2023

As a result, novel IVD manufacturers are more likely to start with clearance of a prescription test intended for use in clinical settings with the thought that one day in the future, after several years of clinical experience demonstrating safe use, they may return to FDA to seek clearance of an OTC version.

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FDA Law Blog

JANUARY 5, 2022

She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. As a Principal Medical Device Regulation Expert, Adrienne will continue to provide consulting to medical device and combination product manufacturers.

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