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)

Manufacturing 52

Manufacturing Government Entertainment Drafting 52

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 2030 ; and that, The global egg market is expected to grow annually by 7.70% (CAGR 2023-2027). be labeled with “Made in USA” or allude to any other indication of U.S. must be disclosed.

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Manufacturing Laws 74

FDA Law Blog

NOVEMBER 22, 2023

The Flavor and Extract Manufacturers Association responded by submitting a food additive petition to FDA, requesting approval to use BVO in beverages at a maximum use level of 15 ppm. Over the past decade, beverage manufacturers have already reformulated their products to replace BVO with these alternatives.

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Manufacturing 52

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. Complaint at 2.

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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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Manufacturing Healthcare Drafting Statute 64

Broadcast Law Blog

MAY 14, 2023

On a rolling basis through April 1, 2027, stations licensed in all other states will be subject to the Mid-Term Review on the fourth anniversary of the filing deadline for their most recent license renewal application.

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Construction Manufacturing Drafting Government 97

The Fashion Law

JANUARY 6, 2022

patents 8,620,413; 9,278,256; 9,259,615; 10,188,930; 10,232,220; and 10,923,225, all of which are utility patents ( as distinct from design patents ), and thus, protect the invention of a new and useful process, machine, manufacture, or composition of matter. .

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Sports Entertainment Technology Manufacturing 81

Broadcast Law Blog

JANUARY 29, 2023

The Copyright Royalty Board published in the Federal Register the proposed rates for the public performance of musical compositions by noncommercial broadcasters for the period 2023 through 2027.

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Sports Manufacturing Statute Laws 98

Customs & International Trade Law

FEBRUARY 19, 2024

The agency extended the test from February 12, 2024, through February 23, 2027, clarified the purpose and scope of the test, and expanded the test to include more entry types and countries of origin. First, the test period has been extended from February 14, 2024 through February 23, 2027.

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Manufacturing Diligence Depositions Government 40

Broadcast Law Blog

JULY 2, 2023

The Republican Attorneys General from 16 states sent a letter to the trade associations representing electric car manufacturers asking that AM radio be preserved in their members’ cars because of the importance of AM to the dissemination of public safety information. These rates are applicable from January 1, 2023 through the end of 2027.

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Manufacturing Construction Calendaring Education 59

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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FDA Law Blog

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

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Court Statute Manufacturing Government 64

ClimateChange-ClimateLaw

AUGUST 22, 2022

The bill is sprawling, covering climate and energy topics as diverse as electric vehicles, building decarbonization, clean energy manufacturing and supply chains, agriculture, and greening the electricity system, all through a range of tax incentives and direct grants.

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Government Technology Finance Healthcare 124

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 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

Manufacturing 45

Manufacturing Project Management Technology Healthcare 45

The Process Street

JULY 30, 2021

Initially, it was a revolutionary material that offered manufacturers and consumers an inexpensive, safe, and sanitary alternative to traditional materials. International Journal of Manpower , [online] 41(7), pp.845–878. DOI: [link]. Yusliza, M.-Y. and Fawehinmi, O.O. Green human resource management. DOI: [link].?.

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Human Resources Education Entertainment Manufacturing 111

The Fashion Law

JUNE 10, 2021

J.Crew has a $400 million exit term loan from Anchorage, GSO Capital Partners LP and others due 2027, and a $400 million asset-based lending credit facility due 2025 from Bank of America NA. The company said its stores and manufacturing operations would continue to operate normally under a restructuring deal reached with most secured lenders.

Finance 125

Finance Court Real Estate Manufacturing 125

ClimateChange-ClimateLaw

DECEMBER 9, 2024

The case involves EPAs 2024 Vehicle Standards that set new air pollutant and greenhouse gas (GHG) emissions standards for model year 2027 through 2032 Light- and Medium-Duty Vehicles, which have been challenged by states and industry groups. The emissions standards become increasingly more stringent over time.

Government 59

Government Technology Manufacturing Court 59

Customs & International Trade Law

JANUARY 31, 2025

Office of Foreign Assets Control (OFAC) OFAC announced a $1,044,781 settlement with a California-based manufacturer of machine tools and related parts regarding its potential civil liability for apparent violations of OFAC’s Ukraine-/Russia-related sanctions. Court of International Trade (CIT) Chinese manufacturer Camel Group Co.

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eFiling Real Estate Manufacturing Laws 40

FDA Law Blog

JUNE 27, 2022

If and when implemented, the amendments will likely force Medicare Part D plans and their PBMs to pass drug manufacturer rebates through to pharmacies to reduce out-of-pocket expenses of Part D enrollees, which would be a dramatic change from current practice.

Laws 52

Laws Manufacturing Finance Litigating 52

Customs & International Trade Law

JANUARY 10, 2025

If genuine, the merchandisewould have an estimated total Manufacturer Suggested Retail Price (MSRP) value of approximately $29,989. Consumer Product Safety Commission (CPSC) The CPSC published a notice announcing that the new eFiling requirements will be effective in stages in 2026 and 2027.

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eFiling Statute Manufacturing Finance 52