FDA Law Blog

MAY 8, 2023

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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FDA Law Blog

JULY 29, 2024

Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products. Part 601 delineates those changes as being either major, moderate, or minor.

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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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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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LawSites

SEPTEMBER 21, 2023

market last December, today is announcing its expansion into contract drafting with the release of LegalOn Templates, a collection of more than 100 market-standard templates created and kept current by attorneys experienced in the applicable area of law. CEO, told me during an interview yesterday. ”

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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Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices.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

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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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

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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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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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

OCTOBER 2, 2024

A draft guidance issued last year focused on PCCPs for devices incorporating artificial intelligence and machine learning (AI/ML), which we blogged about here ; this guidance has not yet been finalized. Draft Guidance at 4. The Draft Guidance takes a narrower approach.

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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

AUGUST 13, 2023

Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities. In the case of contract manufacturers, either the contract manufacturer or the person whose name appears on the label (i.e.,

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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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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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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

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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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

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

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

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

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

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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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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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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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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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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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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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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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

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

NOVEMBER 16, 2021

1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)

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FDA Law Blog

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. CMS will develop a new online portal for manufacturers to review their reports, submit Suggestions of Error, and make rebate payments.

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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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