FDA Law Blog

MAY 13, 2024

RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology. FDA acknowledges that such data offer opportunities to generate evidence and better understand clinical outcomes.

Technology 111

Technology Drafting 111

The Fashion Law

JANUARY 6, 2022

In its complaint, Nike asserts that the technology at the heart of the $1,500 at-home exercise system – which Lululemon brought in-house when it acquired fitness startup Mirror in June 2020 for $500 million – “practice[s] the claimed inventions of [its] asserted patents,” namely, U.S.

Sports 81

Sports Entertainment Technology Manufacturing 81

FDA Law Blog

JUNE 8, 2023

That said, the availability of in-person meetings may differ among the Offices of Health Technology (OHTs). FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition to in-person attendees).

Construction 53

Construction Technology Government 53

The Process Street

DECEMBER 11, 2020

from 2020 to 2027.” – Grand View Research, Property Management Software Market Size. And technology – or to be more specific – top property management software is the driving force behind the evolution. “The global property management software market size was valued at USD 1.58 Real estate is evolving.

Real Estate 105

Real Estate Technology Calendaring Education 105

FDA Law Blog

APRIL 14, 2022

MDUFA V would be applicable to fiscal years 2023 through 2027. The draft MDUFA V commitment letter starts with a 70% goal in FY 2023, but if the de novo decision goal is met in FY 2023 and the fee revenue amount provided for FY 2026 and 2027 is adequate to support performance improvements, FDA plans to increase the goal to 80% in FY 2026.

Drafting 40

Drafting Calendaring Technology 40

Cenza

MARCH 30, 2022

Other challenges include cybersecurity concerns, difficulties with remote work, process workflow optimization, and the adoption of new technology. The global legal process outsourcing (LPO) market, which is predicted to reach US$30 billion by 2027 , has surged as a result of this influence. Industry Trends for LPO.

Document Review 52

Document Review Legal Legal eDiscovery 52

Broadcast Law Blog

MARCH 30, 2023

Our monthly updates, like this one, will thus not be highlighting license renewal dates again until mid-2027. The FCC determined that a review and update of these rules is necessary due to the digital transition, the incentive auction repack, current technology, and changes in Commission practices.

Education 74

Education Contract Technology Legal 74

ClimateChange-ClimateLaw

AUGUST 6, 2015

electric generation in 2027, rather than 28% in 2030 under the finalized Clean Power Plan. When Clinton released her plan only the draft Clean Power Plan was available, which would have led to 25% of energy capacity being from renewable sources in 2027. This value is reflected in her fact sheet.)

Drafting 40

Drafting Technology Legal Legal 40

Conflict of Laws

DECEMBER 27, 2023

It also foresees the use of videoconferencing or other distance communication technology in civil and commercial matters, without prejudice to specific provisions regulating this topic under the Regulation No 2020/1783 (Evidence Regulation), Regulation No 861/2007 and Regulation No 655/2014 (Art.

Legal 59

Legal Legal Technology Laws 59

Rocket Matter

NOVEMBER 3, 2022

By 2027, experts expect the industry to reach a 2.2 Every lawyer needs a comprehensive, agile tech stack to run an efficient legal practice, but with legal tech advancing faster than ever before, it’s easy to get overwhelmed by all the options. (By billion dollar market size globally —so there’s a lot to choose from.) .

Lawyer 40

Lawyer Lawyers Project Management Law Firm 40

ClimateChange-ClimateLaw

AUGUST 22, 2022

billion for a competitive grant and rebate program for the purpose of “purchas[ing] or install[ing] zero-emissions port equipment or technology” at ports. Funds from this appropriation may also be awarded for planning and permitting relating to such zero-emission equipment and technology, and for a port’s climate action planning.

Government 124

Government Technology Finance Healthcare 124

JURIST

NOVEMBER 7, 2023

However, under the new plan, the age of sale will increase by one year annually beginning in 2027. Investigatory Powers (Reform) Bill The proposed legislation will mandate technology firms to provide advance notification to the Home Office regarding any security and privacy features they plan to implement.

Government 129

Government Legal Legal Sports 129

Broadcast Law Blog

JUNE 25, 2023

In addition, the FCC extended through July 17, 2027 the rule that required that the lighthouse signal be “substantially similar” to the primary video stream of the ATSC 3.0 Developers of ATSC 3.0 The Chair of the Judiciary Committee suggested that the Gomez nomination could be approved in July, though Republican Senators reserved judgment.

Construction 64

Construction Technology 64

FDA Law Blog

NOVEMBER 17, 2022

The TAP Pilot is intended to “de-risk the medical device valley of death,” the metaphorical place where innovative technologies die while trying to reach the market. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027). Food & Drug Admin., See Announcement.

Technology 69

Technology 69

FDA Law Blog

JUNE 14, 2023

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. 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

Customs & International Trade Law

FEBRUARY 16, 2024

industry is materially injured by reason of imports that are allegedly sold in the United States at less than fair value and subsidized by the government of China. Office of Foreign Assets Control (OFAC) OFAC sanctioned a procurement network responsible for facilitating the illegal export of goods and technology from over two dozen U.S.

Education 52

Education Technology Laws Government 52

FDA Law Blog

NOVEMBER 21, 2022

The TAP Pilot is intended to “de-risk the medical device valley of death,” the metaphorical place where innovative technologies die while trying to reach the market. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027). Food & Drug Admin., See Announcement.

Technology 59

Technology 59

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. Per MarketWatch, “J.Crew has swapped $1.6 billion in debt with Anchorage Capital Group LLC, which is now the majority owner of the company.

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. However, the Vehicle Standards do not mandate the use of a particular vehicle technology.

Government 59

Government Technology Manufacturing Court 59

Conflict of Laws

DECEMBER 4, 2024

Under the theme ‘The New Frontiers of Party Autonomy,’ several papers were presented concerning party autonomy in different matters, such as non-parity contracts, consumer contracts, new technologies, family law, and dispute resolution, among others. Fernández Arroyo (France).

Laws 59

Laws Contract Family Law Finance 59

Customs & International Trade Law

JANUARY 17, 2025

Bureau of Industry and Security (BIS) BIS announced a regulatory framework for the responsible diffusion of advanced artificial intelligence technology. Department of Homeland Security DHS added 37 new entities to the UFLPA Entity List – the largest expansion of the list at one time. Comments are due May 16, 2025. FDA, along with U.S.

Diligence 52

Diligence Finance Technology Laws 52