FDA Law Blog

JUNE 24, 2021

Cato — On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices , which has been several years in the making. The draft guidance distinguishes between “remanufacturing” and “servicing” of devices. w). “Remanufacturing” is also included in the definition of “manufacturer” in the regulations.

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FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The draft guidance purports to apply to current PMA holders. Draft Guidance. By Jeffrey K.

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FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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FDA Law Blog

NOVEMBER 14, 2022

2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the CARES Act. Livornese — Early Nov.

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FDA Law Blog

DECEMBER 15, 2022

It issued a draft guidance in 2017 which was subsequently revised in 2019. The final guidance issued last week is the same as the 2019 draft guidance except that the final guidance includes a paragraph in which FDA mentions that the provisions of the CARES Act regarding OTC monograph reform do not apply to homeopathic drug products.

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FDA Law Blog

SEPTEMBER 15, 2022

For both draft guidances, it is unclear what induced FDA to publish these draft guidances now. Draft Guidance Regarding the Statement of Identity and Strength for Human Nonprescription Drug Products.

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FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

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LexForti

SEPTEMBER 28, 2021

FRANCHISE AGREEMENT SAMPLE DRAFT. THIS AGREEMENT (the “ Agreement ”) is made this day of , 20 , by and between: Burger Legal Private. The Franchisor grants the right to others to develop and operate BURGER LEGAL Cafes, under the Marks and pursuant to the Licensed Methods. FRANCHISE-AGREEMENT. FRANCHISE AGREEMENT. DEFINITIONS.

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The Fashion Law

OCTOBER 4, 2021

This summer, the European Commission released a draft version of the European Union Vertical Agreements Block Exemption Regulation (“VBER”) along with draft revised guidelines on vertical restraints to supplant the existing guidance on vertical agreements (i.e.,

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The Estrin Report

OCTOBER 15, 2021

The legal field is known to be extremely competitive. For over 20 years, as a former senior legal officer for a Fortune 50 company, Sheila Murphy successfully developed, coached, and transformed talent in corporate America, and law firms. My AHA moment came when the company promoted a peer whose legal skills were lacking.

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MyCase

AUGUST 8, 2022

If you’ve ever used tools like Google Workspace, Microsoft 365, or MyCase legal practice management software, you’re familiar with SaaS—software as a service. SaaS is modernizing the legal industry in two ways: by making law firms more efficient and creating career opportunities for lawyers worldwide. Benefits of Legal SaaS.

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MyCase

AUGUST 8, 2022

If you’ve ever used tools like Google Workspace, Microsoft 365, or MyCase legal practice management software, you’re familiar with SaaS—software as a service. SaaS is modernizing the legal industry in two ways: by making law firms more efficient and creating career opportunities for lawyers worldwide. Benefits of Legal SaaS.

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Patently O

MAY 15, 2024

Section 17 of the bill proposed a use requirement – if a patented invention was not being manufactured or supplied to the public after four years, the patentee would have to grant licenses to others upon demand or else the patent would be forfeited. Section 32 would have overruled A.B. ” The Court rejected the rationale of A.B.

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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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Rocket Matter

MAY 2, 2023

Invented after World War II by Toyota engineers struggling to maintain productivity amid massive supply chain disruptions, lean methodologies revolutionized modern manufacturing. Smart business leaders are always looking for the next big thing and soon adapted the lean principles of manufacturing to everyday business practices.

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Strictly Business

DECEMBER 21, 2023

In most cases, the first draft of an LOI will be used by the buyer to present its formal offer; however, in some cases, the seller will initially present the terms it is willing to accept. It is important that the parties clearly and specifically state which provisions, if any, are legally binding and which are not.

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Patently O

DECEMBER 28, 2022

One of the defendants (Amaxon) sells the accused product, but does not actually manufacture the product. Rather, Amaxon sells a product manufactured by Revloon. Crunch then used that Technical Report to draft an Opinion Letter stating that: “ Amaxon is infringing Dryson’s IP rights.” Should the court certify the class?

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FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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LegalTalkNetwork

FEBRUARY 21, 2018

Legal Talk Network is excited to announce the legal and technology professionals that will be judging the Denver node of the Global Legal Hackathon. Where: Legal Talk Network located at 3120 Blake St. When: February 23-25. Denver, CO 80205. RiNo neighborhood). What: Solutions that improve the business of law.

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The IP Law Blog

JANUARY 26, 2023

101 is a threshold legal issue. Pursuant to 35 U.S.C § 101, “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” Patentability under 35 U.S.C. §

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Customs & International Trade Law

APRIL 22, 2022

On April 15, 2022, the FDA published a draft guidance for industry on developing drugs to treat celiac disease, “Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet.” FDA is alerting consumers there are no FDA-approved or otherwise legally marketed OTC skin lightening products. million, Italy at $72.54

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ClimateChange-ClimateLaw

OCTOBER 16, 2023

produced steel, iron or manufactured products would increase the cost of the facility by more than 25 percent, or where such products “ are not produced in the United States in sufficient and reasonably available quantities or of a satisfactory quality ,” but actionable guidance from the IRS on this point has been limited.)

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SCOTUSBlog

FEBRUARY 28, 2022

The Controlled Substances Act makes it unlawful for “any person knowingly or intentionally … to manufacture, distribute, or dispense” a controlled substance, “[e]xcept as authorized by this subchapter.” Medicine, they contend, is by nature iterative, and the science of pain medicine in particular continues to evolve. (As

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FDA Law Blog

AUGUST 3, 2022

If anything, the announcement was remarkably inconspicuous: a seemingly throwaway sentence in a draft compliance policy guide for research use only and investigational use only products. It has been a long, strange trip ever since. There was no fanfare for this momentous “birth.” See our prior posts here and here.

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Broadcast Law Blog

FEBRUARY 27, 2023

At its March 16 regular monthly open meeting, the FCC will consider a draft Further Notice of Proposed Rulemaking (“FNPRM”) that, if adopted, would formally propose to extend the FCC’s existing audio description requirements for broadcast television to DMAs below the top 100 (i.e., DMAs 101-210).

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The Process Street

APRIL 22, 2021

What is the roadmap to achieve the goals – marketing, operations, research and development, manufacturing, and financial plans? It includes facilities, supply chain management, inventory, manufacturing, shipment, logistics, staff management – everything under the sun that covers capital and expense (CapEx) requirements.

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The Crime Report

NOVEMBER 28, 2022

With more than 200 Americans still dying of drug overdoses each day, states are beginning the high-stakes task of deciding how to spend billions of dollars in settlement funds from opioid manufacturers and distributors. The strife in Ohio highlights the tensions emerging nationwide as settlement funds start flowing.

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Strictly Business

DECEMBER 12, 2023

Therefore, the potential seller should aim to sign an NDA before disclosing any information to the potential buyer; however, if the parties do not, then the potential seller should draft the NDA to ensure that it protects information disclosed prior to the execution of the NDA. This article is for general information only.

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Strictly Business

NOVEMBER 2, 2023

The LOI may also include an exclusivity period and very basic legal terms. The NDA is typically non-binding in terms of the commitment of either party to go forward with the transaction, but it does usually contain some legally binding provisions (such as confidentiality and exclusivity). This article is for general information only.

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Strictly Business

JANUARY 11, 2024

Even though some of the diligence requests relate to business points, the buyer’s deal counsel will typically lead the due diligence process because business points often overlap with legal points. The information presented should not be construed to be formal legal advice nor the formation of a lawyer/client relationship.

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Strictly Business

FEBRUARY 12, 2024

Overview The purchase agreement is the principal legal document used to effect a merger, acquisition, or sale transaction (an “M&A transaction”). The information presented should not be construed to be formal legal advice nor the formation of a lawyer/client relationship. corporations, limited liability companies, etc.),

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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. Change to the IVD definition First, the mechanics of the change.

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FDA Law Blog

MARCH 31, 2024

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chair Brett Guthrie (R-KY), in announcing the hearing, made their views clear: “FDA has proposed a rule that relies upon dubious and misguided legal, economic, and public health arguments and has provided limited opportunities for stakeholders to offer input.

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Conflict of Laws

MAY 20, 2024

It mandates that companies, along with their associated partners in the supply chain, manufacturing, and distribution, must take steps to avoid, halt, or reduce any negative effects they may have on human rights and the environment. Another aspect worthy of attention is how these collective actions would be funded.

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The Fashion Law

OCTOBER 13, 2021

If the non-compete does amount to a restraint of trade, it must be “reasonable” in order to be legally enforceable. However, this highlights a critical issue with the drafting of non-competes. But employment agreements are not the only place where non-compete restrictions come into play.

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ClimateChange-ClimateLaw

MARCH 29, 2024

This post is the third in a series of blogs that address specific legal features of the rule: Part One offered a summary of the final rule, and delved into the materiality threshold that was added throughout the rule, including for greenhouse gas (GHG) emissions disclosure. So: do the SEC or EPA reporting regimes preclude California’s laws?

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FDA Law Blog

FEBRUARY 28, 2022

This Guidance embodies the Agency’s belief that: “Successful adoption of legally marketed medical devices increasingly depends on patient acceptance of that technology and patients being more engaged in the healthcare process, along with demonstrated public health benefits.”.

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