FDA Law Blog

NOVEMBER 7, 2021

We reported that HRSA was proceeding with enforcement actions against drug manufacturers that have declined to sell to 340B covered entities that use multiple contract pharmacies to dispense 340B drugs to their patients, despite the pendency of several lawsuits challenging such enforcement.

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SCOTUSBlog

MARCH 15, 2024

Share As a specific legal question, Tuesday’s bankruptcy case is simple, almost trivial: whether the Bankruptcy Code provisions that permit any “party in interest” to “be heard on any issue” in a Chapter 11 proceeding extend to an insurance company obligated on the claims against an asbestos company during the latter’s reorganization.

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The IP Law Blog

JANUARY 18, 2024

For example, a trade secret can be a manufacturing process, recipe, distribution method for products, research and development information, software algorithm, list of ingredients, list of suppliers, list of customers, pricing strategy, business plan, or advertising strategy. In most cases, reverse engineering is legal.

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FDA Law Blog

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Background. Pfizer’s Petition to SCOTUS.

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FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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Hoban Law Group

JUNE 8, 2021

If you manufacture, distribute, or sell hemp products in the U.S., First, ensure your product label adheres to federal labeling regulations governing the type of product you are manufacturing, distributing, or selling. 5) Name and Place of Business of the Manufacturer, Distributor or Packer. Supplement Facts panel); and. (5)

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FDA Law Blog

AUGUST 26, 2021

In its Compliance Guidance for Pharmaceutical Manufacturers , the HHS OIG notes: The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer.

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Customs & International Trade Law

NOVEMBER 23, 2021

now states: “Products of the United States when returned after having been exported, or any other products when returned within 3 years after having been exported, without having been advanced in value or improved in condition by any process of manufacture or other means while abroad.” manufacturer are not clearly stated. claim (p.s.

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FDA Law Blog

FEBRUARY 5, 2023

Both courts found the statute to be ambiguous, but only the Delaware court vacated HRSA’s penalties; the New Jersey court remanded the issue to HRSA. Last week, a panel of three judges at the Third Circuit who reviewed these three cases decided in favor of the drug manufacturers. A lot is at stake here.

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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. Of course, the statute says that only drug formulation, composition, or method of use patents are listable, but FDA has not defined the scope of the “drug” that must be covered by the patent.

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The Fashion Law

FEBRUARY 10, 2022

And wven without Rogers and the First Amendment, they note that “the federal dilution statute expressly excludes ‘noncommercial’ uses,” which is what is at play here, they argue, given the artistic elements of Rothschild’s MetaBirkins. As for what brands stand to gain in legal battles over NFTs, we take a look at that here.

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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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Manufacturing Healthcare Court Statute 60

FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? However, FDA’s legal standing to insist on cybersecurity features, especially within the substantial equivalence paradigm, has been questionable. Now, with explicit statutory authority, FDA’s push for cybersecurity has a firm legal footing. By Philip Won & Jeffrey K.

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SCOTUSBlog

DECEMBER 3, 2023

And should the parties in a tort litigation be permitted to bypass discovery and the adjudication of legal liability in the interest of reaching a global settlement and getting money to victims, cities, and states? Although the statute formally allows for only pre-trial consolidation, 99% of cases consolidated into MDL settle.

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Litigation Litigating Tort Statute 101

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.

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Patently O

MAY 8, 2024

Zircon is the latest in a series of appellate decisions focusing on the nuance of domestic industry, especially in our era where so many products are manufactured abroad. The court noted that the domestic industry statute, 19 U.S.C. Of course, this assumes that such a domestic industry exists. ” 19 U.S.C. 1337(a)(2).

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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? The Kentucky AG uniquely adds that FDA’s proposal improperly interferes with the Commonwealth’s exercise of supervisory authority over its physicians, including statutes addressed to obtaining informed consent.

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The Process Street

NOVEMBER 28, 2023

Applications of AI manufacturing AI has various applications in manufacturing that are revolutionizing the traditional methods and streamlining the processes. Enhanced safety AI-powered systems can identify and prevent potential hazards in the manufacturing environment.

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Patently O

MARCH 9, 2022

But, in the 1800s, Congress created a special statute that substantially limits proper venue in patent cases (well before the expansion seen in Section 1391. In Fourco (1957), and again in TC Heartland (2017), the Supreme Court gave weight to the patent-focused statute. Thus, for most federal cases, venue is not a major hurdle.

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Constitutional Law Reporter

MARCH 4, 2025

The issue before the Court is whether the Hobbs Act required the district court in this case to accept the FCCs legal interpretation of the Telephone Consumer Protection Act. The Court has agreed to determine [w]hether a manufacturer may file a petition for review in a circuit (other than the D.C. Food and Drug Administration v.

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Manufacturing Court Constitutional Law Statute 52

FDA Law Blog

OCTOBER 4, 2023

As such, that statute was unjust, confiscatory and violated their constitutional due process rights. Because Plaintiffs are not legally compelled to participate in the Program—or in Medicare generally—they have not shown a strong likelihood of success on the merits of their due process case.” Order at 24.

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Customs & International Trade Law

SEPTEMBER 17, 2021

According to the State Department, Keysight cooperated in the investigation by submitting a voluntary disclosure that acknowledged the charged conduct, implemented remedial compliance measures, and signed a statute of limitations agreement tolling the statutory period. In-House Legal Counsel . Department of Commerce; the U.S.

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Conflict of Laws

NOVEMBER 23, 2023

Apart from customary international law, it is also doubtful that Meng’s conduct in Hong Kong fell within the scope of the federal bank and wire fraud statutes. conduct is required under the federal bank and wire fraud statutes, Meng engaged in no U.S. In their comprehensive legal analysis of U.S. Although U.S. conduct at all.

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ClimateChange-ClimateLaw

JUNE 14, 2023

Most of the rhetoric and activity has occurred in the first two categories in the US, so we focus there, in an effort to differentiate political narratives from legal reality. There are several statutes that form the basis of our antitrust laws. And what are the permissible boundaries of that behavior?

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FDA Law Blog

NOVEMBER 7, 2023

But there’s no telling what the implicated manufacturers will do, because again, it is legally unclear whether the listing of the device patents is actually anticompetitive. FDA has asked for comments and published a report, but really nothing has come of that other than repeated requests from industry for guidance in this space.

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FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. But, by statute all devices not previously classified are automatically placed into Class III.

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FDA Law Blog

DECEMBER 20, 2021

FDA did not consider that NAC was legally marketed as a dietary supplement before 1994. As a matter of statutory construction, absent explicit language, statutes are generally intended to apply prospectively. Seemingly that should give a plaintiff standing. Second, was DSHEA intended by Congress to apply retroactively?

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The IP Law Blog

JUNE 16, 2022

However, the FDA notes that delta-8 THC does not appear “in significant amounts in cannabis plants so it is often manufactured from hemp-derived cannabidiol.”. On the other hand, AK Futures argued that delta-8 THC fell within the definition of hemp, which Congress had legalized in its 2018 Farm Act. on a dry weight basis.”

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Laws Manufacturing Litigating Litigation 52

FDA Law Blog

AUGUST 8, 2024

Rescheduling or descheduling from the most stringent schedule under the CSA, should one of those actions occur, would loosen federal manufacturing, import/export, distribution, and security requirements. Every state has enacted its own controlled substances statutes and regulations, many of which mirror the federal CSA and DEA regulations.

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Conflict of Laws

SEPTEMBER 15, 2024

During these three weeks, six special courses were given by Alessandra Zanobetti (Professor at the University of Bologna) on “The Effects of Economic Sanctions and Counter-Measures on Private Legal Relationships”; Natalie Y. In this way, PIL facilitates legal pluralism. On the basis of case law in England and the U.S.

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FDA Law Blog

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately.

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Conflict of Laws

MAY 17, 2022

They are intended to render legal disputes plannable and predictable. Nordmeier : International jurisdiction and foreign law in legal aid proceedings – enforcement counterclaims, section 293 German Code of Civil Procedure and the approval requirements of section 114 (1) German Code of Civil Procedure.

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Customs & International Trade Law

OCTOBER 28, 2022

DOC determines that imports of quartz slab manufactured in the People’s Republic of China (China) and processed in Malaysia are covered by the scope of the antidumping duty (AD) and countervailing duty (CVD) orders on certain quartz surface products from China. . Secretary of Commerce has determined that U.S.

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FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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Customs & International Trade Law

NOVEMBER 7, 2022

Defendant United States argued that, although Washington State repealed its laws criminalizing possession of marijuana paraphernalia like the Twisted Trimmer, that repeal does not explicitly authorize Keirton to use the subject merchandise to manufacture, possess, or distribute marijuana paraphernalia under Federal law.

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Laws Manufacturing Court Statute 40

Customs & International Trade Law

OCTOBER 4, 2021

1592 is the statute CBP utilizes when issuing penalties, based upon whether CBP believes an importer was negligent, grossly negligent or fraudulent when using an incorrect HTS. The GRI are legal and binding rules used to determine classification. In-house Legal Counsel. Penalties for non-compliance can be severe.

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Patently O

JUNE 15, 2021

Although it required invention in name, it was really just becoming a replacement to monopolies barred by the Statute of Monopolies (1624). . Exactions and frauds, in all the forms which rapacity can suggest, are daily imposed and practised under the pretence of some legal sanction. Van Ness argues that the U.S.

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