FDA Law Blog

DECEMBER 12, 2023

Acknowledging concerns about urolithiasis, pet food manufacturers use a range of formulation strategies to make UTH cat food, which have included limiting the magnesium content or formulating it to produce slightly acidic urine.

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FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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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

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.

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Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended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 The draft guidance purports to apply to current PMA holders. Draft Guidance.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

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Cato — On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices , which has been several years in the making. The draft guidance distinguishes between “remanufacturing” and “servicing” of devices.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

FEBRUARY 26, 2024

OECD reported that immigrants accounted for over 20 percent of the total employment, mainly in sectors such as manufacturing, fishing, tourism and construction. The ministry appointed a steering committee and began work in early 2023 to draft a policy on immigrant and refugee matters.

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LLRX

MAY 24, 2023

Jordan Furlong writes - the legal profession is about to go through what manufacturing already has. An enormous amount of lawyer activity consists of researching, analyzing, writing, developing arguments, critiquing counter-claims, and drafting responses.

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FDA Law Blog

NOVEMBER 29, 2023

Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions. Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change.

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FDA Law Blog

MARCH 7, 2022

Mullen — In late December, as cases of Omicron were soaring, CDRH issued two draft guidance documents to prepare for the end of the public health emergency. The pair of draft guidances laid out the transition for devices that are being marketed under an EUA and devices being marketed subject to enforcement discretion policies.

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FDA Law Blog

OCTOBER 27, 2022

Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.”

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LexForti

SEPTEMBER 28, 2021

FRANCHISE AGREEMENT SAMPLE DRAFT. All payments shall be made by the Franchisee by way of a bankers cheque/demand draft made payable at ……………… (place) in favour of the Franchisor. The post A Sample draft of Franchise Agreement appeared first on LexForti Legal News & Journal.

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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.” In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., products intended for medical purposes).

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FDA Law Blog

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). By Kalie E. Richardson & Karla L. 353b(a)(8). the wholesale distributor, repackager, relabeler).

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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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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.” In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., products intended for medical purposes).

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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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JURIST

MARCH 3, 2022

The United Nations Environment Assembly Wednesday approved a resolution to establish the first-ever global agreement on plastic pollution, along with a series of draft resolutions concerning biodiversity, health, the green economy, and circularity. The United Nations estimates the global plastic industry is valued at US$522.6

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FDA Law Blog

SEPTEMBER 6, 2022

Livornese — FDA recently published a Draft Guidance entitled “Charging for Investigational Drugs under an Investigational New Drug Application: Questions and Answers” (the Draft Guidance). This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Not all that much.

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FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. In addition to providing additional examples of tree nuts, the draft guidance states that FDA considers the following categories of fish to be major food allergens under Section 201(qq): Jawless fish (e.g.,

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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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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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FDA Law Blog

FEBRUARY 9, 2024

We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ). Drug or biologic sponsors should engage with manufacturers of DHTs to ensure appropriate evidence has been established for the DHTs before use in a clinical study.

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JURIST

DECEMBER 16, 2021

” Newsom had his own fair share of words on the decision and explained his directive to authorize private citizen suits against gun manufacturers and distributors: “I am outraged by yesterday’s U.S. Newsom has been a roll since convincingly surviving a recall effort against him in September.

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JURIST

JANUARY 21, 2023

For instance, on 21 May 2020, The Wire, an independent news organization in India, published a report about how certain ventilators procured by the government during the pandemic were of poor and substandard quality and how the company which manufactured it may have ties to the ruling government.

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Patently O

JULY 6, 2021

See American Axle & Manufacturing, Inc. On appeal, the Federal Circuit affirmed without opinion (R.36). Now, VoIP-Pal has petitioned for writ of certiorari. The case is now part of a trio of eligibility cases pending before the Court. Neapco Holdings LLC , No. 20-891; iLife Technologies, Inc. Nintendo of America, Inc. ,

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Customs & International Trade Law

FEBRUARY 9, 2024

Food and Drug Administration (FDA) The FDA issued draft guidance for industry to provide recommendations for collecting representative samples for seafood products subject to Detention Without Physical Examination (DWPE).

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FDA Law Blog

JANUARY 5, 2022

As a Principal Medical Device Regulation Expert, Adrienne will continue to provide consulting to medical device and combination product manufacturers. In the premarket area, Adrienne prepares IDEs, 510(k)s, de novos, and PMAs.

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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. Therefore, the parties should expressly disclaim good faith if they do not want that obligation to be imposed as an implied term.

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Strictly Business

MARCH 18, 2024

Despite their utility, earnouts must be carefully negotiated and drafted to reduce the likelihood of future disputes and thwarted expectations, particularly in cases tied to bottom-line results, complex calculations, and/or when the target company is being integrated into the buyer’s other businesses.

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Real Estate Drafting Business Services Manufacturing 72

The Estrin Report

JANUARY 30, 2023

Manufacturers always have a manual of practical information. For example, as many clients want to be more involved in processing their files, a second client monitor on a lawyer’s desk allows the client to collaborate in order to finalize draft documents and to produce financial calculations. Why not have one for lawyers?

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FDA Law Blog

JANUARY 5, 2022

As a Principal Medical Device Regulation Expert, Adrienne will continue to provide consulting to medical device and combination product manufacturers. In the premarket area, Adrienne prepares IDEs, 510(k)s, de novos, and PMAs.

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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.

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FDA Law Blog

MARCH 7, 2024

Gibbs — Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales for the most recent tax year, are eligible for a reduced fee on those medical device submissions that require a user fee.

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FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The VMSR Program allows manufacturers to bundle malfunction reports of “like events” together in a single summary report. In that letter, FDA stated that it would “permit manufacturers.

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FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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FDA Law Blog

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection.

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