Customs & International Trade Law

MARCH 15, 2022

On December 23, 2021, the FDA issued two draft guidance documents in the Federal Register detailing its proposed medical device transition plans for all medical devices previously imported under the two aforementioned government declarations. Whether the manufacturer plans to submit a marketing submission. contact information).

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Drafting Manufacturing Government Laws 52

FDA Law Blog

AUGUST 10, 2023

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. FDA has resumed on-site inspections of foreign facilities focused on current Good Manufacturing Practices (cGMP) but has continued issuing records requests under Section 704(a)(4), which spurred this latest round of warning letters.

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Manufacturing Drafting 52

JURIST

MAY 9, 2024

China sought to solicit public opinion towards the draft regulations , aiming at regulating its rapidly growing lithium battery industry on Wednesday. The draft regulations address the environmental impact of the lithium battery industry. The draft regulations also come as the U.S. Last year, the US government announced $3.5

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Drafting Manufacturing Technology Government 129

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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Drafting Manufacturing Laws 59

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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Drafting Manufacturing Education Legal 45

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By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program.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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Drafting Manufacturing Technology Healthcare 45

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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Drafting Manufacturing Legal Legal 52

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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Drafting Manufacturing Legal Legal 52

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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Immigration Education Manufacturing Construction 196

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.

Lawyer 101

Lawyer Lawyers Legal Legal 101

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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Drafting Data Management Manufacturing Healthcare 115

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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Drafting Manufacturing 52

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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Manufacturing Drafting 105

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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Drafting Legal Legal Manufacturing 52

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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Healthcare Manufacturing Drafting Construction 98

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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Drafting Manufacturing Healthcare 52

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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Manufacturing Drafting Contract Legal 64

FDA Law Blog

JUNE 30, 2024

Lenz brings a wealth of experience, having provided consulting to medical device and combination product manufacturers on a wide range of pre and postmarket regulatory topics. Her expertise includes developing regulatory strategies, preparing regulatory submissions, drafting policies and procedures, and addressing enforcement matters.

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Diligence Manufacturing Drafting Technology 52

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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Healthcare Manufacturing Drafting Construction 75

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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Drafting Manufacturing Legal Legal 98

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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Manufacturing Drafting Legal Legal 197

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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Drafting Manufacturing Government 52

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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Laws Drafting Manufacturing Court 111

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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Drafting Manufacturing Education Technology 59

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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Manufacturing Calendaring Statute Administrative Law 105

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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Drafting Manufacturing Technology Legal 64

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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Court Manufacturing Attorney Court Decisions 208

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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Technology Manufacturing Drafting 105

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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Government Manufacturing Drafting Technology 197

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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Manufacturing Drafting Technology Court 143

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.

Healthcare 40

Healthcare Manufacturing Drafting 40

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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Lawyer Lawyers Legal Services Law Firm 238

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).

Technology 52

Technology Drafting Manufacturing Government 52

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.

Healthcare 40

Healthcare Manufacturing Drafting 40

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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Diligence Drafting Contract Real Estate 83

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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Laws Manufacturing Drafting Technology 105