FDA Law Blog

MARCH 9, 2025

The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY.

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FDA Law Blog

MARCH 25, 2025

Within the Notification, FDA references a General Correspondence Letter (GCL) sent on February 26, 2025. FDA has recently issued an updated Notifications on Data Integrity Medical Devices.

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Manufacturing 59

FDA Law Blog

FEBRUARY 11, 2025

Gaulkin Drug manufacturers wont be receiving their first invoices for Medicare Part B and Part D inflation rebates until later this year, but rebates have been accruing since first quarter 2023 for Part B rebates and October 2022 for Part D rebates. The webinar will explore the legal and operational considerations for drug manufacturers.

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Manufacturing Legal Legal Government 59

FDA Law Blog

SEPTEMBER 11, 2024

Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. For example, depending on the manufacturing process for a specific human drug, the use of some specific solvents, reagents, and catalysts may trigger the formation of these possible carcinogens.

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Manufacturing 105

FDA Law Blog

FEBRUARY 27, 2025

The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. And it is exactly that!

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Manufacturing Legal Legal Laws 59

Mondaq

NOVEMBER 23, 2021

Selling web users' personal data is big business — with a projected worth of $400 billion by 2025. In industries as diverse as health insurance and automobile manufacturing.

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Intelligize Blog

MARCH 19, 2025

The Centers for Disease Control and Prevention is reporting sharp year-over-year increases in its estimates of indicators such as flu-related hospitalizations for the 2024-2025 cycle. billion; and Aerospace manufacturer Triumph Group Inc. Flu season has hit the United States with a vengeance this year. a price of approximately $6.25

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Manufacturing Drafting Technology 62

Constitutional Law Reporter

DECEMBER 11, 2024

gun manufacturers. Estados Unidos Mexicanos , alleges the manufacturers aided and abetted the illegal sales of guns to traffickers for cartels in Mexico. gun manufacturers and one gun distributor. A decision is expected before the end of the term in June/July 2025. The suit, Smith & Wesson Brands v.

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Manufacturing Government Constitutional Law Court 98

Patently O

FEBRUARY 6, 2025

by Dennis Crouch The Federal Circuit has affirmed the PTAB finding of obviousness in an inter partes review (IPR) challenge to an integrated circuit manufacturing patent, even while disagreeing with the Board's claim construction. HD Silicon Solutions LLC v. Microchip Technology Inc. , 2023-1397 (Fed.

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Construction Manufacturing Technology 40

FDA Law Blog

FEBRUARY 26, 2025

Trusting suppliers is still fundamental to any drug or device manufacturer. A 2025 study reported by Radical Compliance found that while senior management often believes in the robustness of their ethical culture, employees at other levels do not. Department of Justices Consumer Protection Branch.

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JURIST

MAY 14, 2024

Besides maintaining the 2025 emissions reduction target of 15 percent for heavy trucks, the regulation also establishes new targets. The law called for a gradual reduction of the eco-innovation credits available to manufacturers and regular reports detailing progress toward these goals. The regulation proposes various objectives.

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Manufacturing Laws 118

JURIST

JUNE 20, 2022

The manufacture and importation of single-use plastics will be banned in December 2022. Further, the Canadian Government “will also prohibit the export of [banned] plastics … by the end of 2025[.]” However, specific case exceptions will be included, including medically-necessary flexible straws.

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Customs & International Trade Law

OCTOBER 25, 2024

Trade Representative announced certain modifications to the actions taken in the Section 301 investigation including a list of subheadings eligible for consideration of temporary exclusion under an exclusion process for certain machinery used in domestic manufacturing. The deadline for submitting exclusion requests is March 31, 2025.

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Manufacturing Technology Laws 40

FDA Law Blog

JANUARY 16, 2025

Hyman, Phelps & McNamara PC, (HPM), which will mark its 45thAnniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the year. Richardson has been promoted to Director. Kalie is the quintessential HPM lawyer.

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Law Firms Law Firm Manufacturing Law School 59

ClimateChange-ClimateLaw

MARCH 27, 2025

On March 18, 2025, Judge Ronnie Abrams dismissed the lawsuit with prejudice , penning an opinion that upholds Local Law 154 as a valid exercise of local authority beyond the purview of EPCAs preemption clause. In other words, EPCAs text and structure clearly intended to avoid a patchwork of conflicting and unpredictable regulations.

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Laws Court Construction Government 59

Fordham Law News

OCTOBER 30, 2024

8] In his decision, Judge Mehta concluded that Google violated antitrust laws by striking exclusive agreements with device manufacturers such as Apple and Samsung. [9] 8] In his decision, Judge Mehta concluded that Google violated antitrust laws by striking exclusive agreements with device manufacturers such as Apple and Samsung. [9]

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Manufacturing Government Laws Technology 52

FDA Law Blog

FEBRUARY 4, 2025

Koblitz Last December, Congress narrowly avoided a shutdown by significantly paring down the originally proposed 2025 Appropriations bill, slashing away hundreds of programs and laws. The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs.

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Drafting Manufacturing Laws 52

The Fashion Law

AUGUST 11, 2021

Gucci-owner Kering group, for example, has set a target to reduce greenhouse gas emissions by 50 percent by 2025. Meanwhile, LVMH used its perfume manufacturing facilities to make free hand sanitizer for the healthcare system in France.

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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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Manufacturing Government Entertainment Drafting 52

ClimateChange-ClimateLaw

OCTOBER 16, 2023

In 2025, that reduction in base credit will increase to 15 percent and in 2026, the base credit amount for direct pay claimants that cannot achieve the domestic content requirements will be reduced by 100 percent. If they can’t, they won’t be able to claim the ITC, even though it is notionally available until 2032.

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Government Manufacturing Finance Drafting 137

Customs & International Trade Law

MARCH 26, 2025

MoCRA Requirements: FDA registration for cosmetics facilities Product listings for each cosmetic product Adverse event reporting Safety substantiation Compliance with Good Manufacturing Practices (GMPs) Fragrance allergen labeling MoCRA also gives the FDA new records access and mandatory recall authority.

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FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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Manufacturing Education Small Business Calendaring 64

FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. issues with the design, manufacturing, and components of the device).

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Manufacturing Healthcare Education 64

FDA Law Blog

JULY 17, 2022

Under the new law, Part B will continue to pay for discarded amounts from single-dose containers, but the manufacturer must pay a rebate (called a “refund”) to Medicare for discarded amounts above a specified threshold. The manufacturer responsible for paying the refunds will be the company whose NDC is on the label.

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Manufacturing Statute Government Laws 52

Customs & International Trade Law

DECEMBER 26, 2024

Bureau of Industry and Security (BIS) BIS imposed a $180,000 mitigated penalty against Indium Corporation for 11 exports of electronics manufacturing components to Russia. Fruit juice manufacturing company and its former president plead guilty to food safety crimes. genetically modified corn exports violate the U.S.

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Manufacturing Drafting Government Laws 52

Strictly Business

FEBRUARY 29, 2024

For those reporting companies established or registered before January 1, 2024, the deadline for the initial BOI report is January 1, 2025. For more information about our services, please visit www.riggsdavie.com or contact our practice group by email at dealteam@riggsdavie.com.

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Diligence Calendaring Real Estate Business Services 89

The Fashion Law

AUGUST 9, 2021

Both Boohoo and Shein have garnered consumer pushback as a result of their labor exploitation, particularly given growing consumer awareness of – and demand for transparency when it comes to – the supply chain issues that are commonly tied to fast fashion, and other types of apparel manufacturing, as well. billion by the end of 2025.

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Manufacturing Contract Diligence Attorney 109

Customs & International Trade Law

JANUARY 10, 2025

What Food Manufacturers Should Do The rule is effective February 25, 2025, and the compliance date of the rule is February 25, 2028. In preparation for the compliance date, food manufacturers should review their products to ensure that any product that uses a healthy label meets the new criteria.

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FDA Law Blog

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). N/A June 30 The manufacturer must accept the price or counteroffer—with a rationale. CMS may respond to the counteroffer.

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Customs & International Trade Law

MARCH 14, 2023

The exception to this is for textile, wool, and fur products as processing or manufacturing occurring in the U.S. billion by 2025, and at a CAGR of 6.8% The similarity in the rules is that neither Customs nor the FTC requires that goods made partially or wholly in the U.S. must be disclosed. billion to $604.34 to nearly $465.7

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Manufacturing Laws 74

Customs & International Trade Law

SEPTEMBER 17, 2024

1, 2024, and through May 31, 2025. Machinery exclusions – In response to a directive from the President to establish a process by which interested persons may request that machinery used in domestic manufacturing be excluded, USTR added 312 subheadings to be eligible for consideration for temporary exclusions.

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Manufacturing Technology Laws 40

ClimateChange-ClimateLaw

JUNE 27, 2023

Eligible Tax Credits : The tax credits for which a local government may elect to receive direct payment are as follows (numbers are references to the applicable Internal Revenue Code provisions): 30C (alternative fuel refueling property) : up to a 30% tax credit for cost of natural gas, propane, hydrogen, electricity, E85, or diesel fuel blend vehicle (..)

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Government Finance Manufacturing Technology 111

FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” up to 125 total products enrolled through FY 2025). up to 60 total products enrolled through FY 2024).

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Manufacturing Project Management Technology Healthcare 45

Broadcast Law Blog

FEBRUARY 27, 2023

The FCC proposes to extend these requirements to DMAs 101-210 by phasing in 10 DMAs per year starting on January 1, 2025, meaning that the bottom 10 DMAs would not be phased in until January 1, 2035. additional hours of audio description per calendar quarter between 6 a.m. and 11:59 p.m. local time.

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Calendaring Manufacturing Drafting Contract 97

Constitutional Law Reporter

MARCH 4, 2025

.” The Fifth Circuit Court of Appeals has determined that a manufacturer may seek judicial review in that circuit even if it neither resides nor has its principal place of business there, so long as its petition is joined by a seller of its products, such as a gas station or convenience store, based in the circuit. Cunningham v.

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Manufacturing Court Constitutional Law Statute 52

ClimateChange-ClimateLaw

AUGUST 1, 2024

The grants, made in July 2023, were offered on a formula basis – $3 million for states and $1 million for MSAs – and grantees are required to complete three deliverables: a Priority Climate Action Plan (PCAP) that was due earlier this year, a Comprehensive Climate Action Plan (CCAP) due June 2025, and a status report due June 2027.

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Finance Government Manufacturing Laws 122

FDA Law Blog

SEPTEMBER 20, 2021

Notable Dates and Timelines – Program opens, beginning of FY 2023; Expediting reviews fully implemented, by FY 2024; Webpage with detailed criteria for acceptance and participation, October 1, 2022; Interim assessment, end of FY 2025; Public workshop, end of Q2 FY 2026. Notable Dates and Timelines – New MAPP published, by Dec.

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Drafting Manufacturing Meetings Minutes Technology 52