LawSites

JANUARY 31, 2024

The new platform already has screens published by experts in commercial real estate, privacy, fintech, SaaS, healthcare, consumer, and more. Creating a screen to draft an efficient, enforceable and cost-effective dispute resolution provision allows the AAA to share its decades of leadership and expertise in the field.”

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Contract Lawyer Lawyers Real Estate 122

FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today.

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Manufacturing Healthcare Drafting Construction 98

LegalReader

FEBRUARY 1, 2023

California estate planning lawyers can guide individuals on California estate laws as they decide to draft relevant documents to plan for their end-of-life care, death, and asset distribution.

Healthcare 59

Healthcare Drafting Lawyer Lawyers 59

LDA PRO

JULY 12, 2022

Healthcare Directive. Like its cousin, the durable power of attorney, a healthcare directive authorizes someone to make decisions if you are incapacitated. However, the Advanced Healthcare Directive (ACHD) limits this authority to medical decisions. Have specific questions about how to draft valid documents?

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Legal Document Assistant Legal Documents Healthcare Attorney 130

FDA Law Blog

NOVEMBER 22, 2021

Over the past 16 years, there have been numerous advances in healthcare technology, particularly with respect to the use of software in and as a medical device. The new draft guidance applies to both Software in a Medical Device (SiMD) which would be your traditional hardware with embedded software and Software as a Medical Device (SaMD).

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Drafting Healthcare Technology 52

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 Draft Guidance Regarding the Statement of Identity and Strength for Human Nonprescription Drug Products. For both guidances, comments must be submitted by November 8, 2022, to be considered by FDA.

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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

LDA PRO

JUNE 27, 2023

An LDA is a trained professional who can assist with document preparation, ensuring that your gift deeds in California is properly drafted, executed, and filed with the appropriate county office. Our LDAs can help you draft and execute quitclaim deeds to facilitate property transfers.

Legal Document Assistant 130

Legal Document Assistant Legal Legal Legal Documents 130

FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today.

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Healthcare Manufacturing Drafting Construction 75

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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Law 360

NOVEMBER 25, 2024

The California Privacy Protection Agency on Friday opened the public comment period for its latest rulemaking package proposing expansive draft rules regulating technologies fueled by artificial intelligence — including in the employment, education, healthcare, consumer protection, banking and insurance contexts — which business groups have already (..)

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Healthcare Drafting Education Technology 52

LDA PRO

JANUARY 14, 2021

Our Revocable Living Trust Package Includes: Revocable Living Trust, Trust Certification, Real Property Transfer Deed, Pour Over Will, Power Of Attorney, and Healthcare Directive. If you do not have any experience in deed drafting, you should not risk making one yourself.

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Paralegal Paralegals Legal Document Assistant Real Estate 130

LDA PRO

JULY 24, 2023

Beyond Wealth Distribution Estate planning is not solely about distributing your wealth; it encompasses many aspects of your life, including healthcare decisions, guardianship of minor children, and even planning for possible incapacitation. LDA Pro Legal is your trusted partner in estate planning and legal services.

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Paralegal Bootcamp

APRIL 8, 2022

For instance, commercial litigation paralegals can benefit from CLEs explaining the methods of determining the appropriate type of business organization or drafting contracts. Museum exhibits and podcasts personalize significant court cases or legal developments such as the evolution of labor or environmental laws.

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Paralegal Paralegals Education Real Estate 246

JURIST

SEPTEMBER 29, 2022

The entire nation, home to 225 million people, is utterly devastated as floods erase lives, roads and buildings alike, spawning healthcare and food crises on top of the country’s already precarious political and economic situation. Ten children breathe their last each day at Sindh province’s Mother and Child Healthcare Hospital alone.

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Finance Healthcare Government Legal 253

FDA Law Blog

JUNE 21, 2023

According to the announcement, enabling patients to access medical devices beyond traditional clinical settings can help close the healthcare gap by delivering care “directly to patients, wherever they are – at home, at work, in cities, in rural communities.” telemedicine and telehealth solutions (e.g.,

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Technology Healthcare Drafting 45

ClimateChange-ClimateLaw

FEBRUARY 7, 2023

By Matthew Eisenson On January 27, 2023, the Sabin Center submitted comments on the draft Fifth National Climate Assessment (NCA5). Key Takeaways and Focus Areas of the Sabin Center’s Comments on the Draft NCA5 The Sabin Center submitted 10 sets of comments on the draft NCA5.

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Drafting Government Small Business Legal 52

The Estrin Report

MAY 12, 2023

For example, AI can facilitate more accurate diagnoses in the healthcare sector and allow doctors to focus on providing better patient care rather than being bogged down by administrative tasks. By leveraging AI technology, tools such as BriefPoint.ai

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Document Review Legal Technology Solution Technology Legal 246

FDA Law Blog

JANUARY 24, 2023

Legal has already drafted a cease and desist letter on the matter (to which the competitor has essentially said “ pound sand ”), and Legal has also drafted and submitted a trade complaint to FDA that has not produced any action to speak of.

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Healthcare Drafting Legal Legal 59

Day on Torts

MARCH 10, 2023

In an HCLA case discovery dispute, the Tennessee Court of Appeals ruled that plaintiff’s testifying experts’ “notes, drafts, and communications with counsel” were discoverable under the Tennessee Rules of Civil Procedure and that plaintiff had waived any claim that the requested items were privileged. In Starnes v. Akinlaja , No.

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Depositions Drafting Healthcare Court Rules 52

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). Draft Guidance III.B.2(e) Draft Guidance III.B.2(d) By Kalie E. Richardson & Karla L. 353b(a)(8).

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Drafting Manufacturing Healthcare 52

FDA Law Blog

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. The PR goes on to state that the FD&C Act definition of a device does not turn on where or by whom a test system is “manufactured.”

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Manufacturing Healthcare Drafting Legal 81

FDA Law Blog

APRIL 25, 2023

The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers. It applies whether the software is the entire device (i.e., Software in a Medical Device, or SiMD).

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FDA Law Blog

JANUARY 5, 2022

She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo. In the premarket area, Adrienne prepares IDEs, 510(k)s, de novos, and PMAs.

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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt develops regulatory strategies, prepares pre-submissions and regulatory market authorization submissions, drafts regulatory policies and procedures, and reviews advertising and promotional materials. In the pre-market area, Ms. In the post-market area, Ms.

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FDA Law Blog

JUNE 25, 2024

Accordingly, FDA issued this new draft guidance that, when finalized, will revise certain sections of another guidance document, Considerations in Demonstrating Interchangeability With a Reference Product, which was written before FDA had received and reviewed any interchangeable biosimilar applications.

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FDA Law Blog

JANUARY 5, 2022

She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo. In the premarket area, Adrienne prepares IDEs, 510(k)s, de novos, and PMAs.

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MorneauLaw

JUNE 30, 2023

We are offering a special package price for college students to receive these 3 essential documents through the end of August. Attorney St.

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FDA Law Blog

MAY 26, 2022

You see, we are fortunate enough to often get our hands on pieces of draft legislation thought up by folks – like FDA – who peddle ideas on how to change the law. And that brings us to FDA’s draft legislation to make reality one of the Legislative Proposals the Agency included in its Fiscal Year 2023 Budget Justification. destructive.

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FDA Law Blog

AUGUST 23, 2023

A DHT is considered “a system that uses computing platforms, connectivity, software, and sensors for healthcare and related uses.” FDA also released, in December 2021, draft guidance for Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.

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Technology Drafting Healthcare 52

LawSites

MAY 30, 2023

The law firm, Nextpoint Law Group (NLG), will provide discovery and litigation legal services to other law firms and to corporate legal departments, including trial strategy, early case assessment, document review, discovery drafting, legal research and brief writing. Its lawyers will not appear in court.

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eDiscovery Law Firms Law Firm Document Review 98

FDA Law Blog

JULY 15, 2021

As part of its initiatives on this front, FDA issued a Draft Guidance in February 2020 on Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products (Biologics Promotional Guidance). The use of the proper name (i.e., Neulasta Onpro).

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LawSites

JANUARY 23, 2023

CiteRight Elevator Pitch: CiteRight helps litigation teams save, organize, share, cite, and assemble case law — so they can draft faster and spend more time on what matters. ContractKen Elevator Pitch: ContractKen is building the next generation contract drafting & review solution called ReviewKen.

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Court Reporting Legal Technology Solution Contract Law Firms 98

MorneauLaw

JANUARY 31, 2023

O ften when Clients hire the Firm to draft their estate plan, the Attorney will recommend including a Nomination of Guardian document as part of their plan. Share This Story! What is a Nomination of Guardian?

Attorney 52

Attorney Drafting Court Laws 52

FDA Law Blog

DECEMBER 13, 2022

Since very few specimen collection devices include home use indications and FDA could take the view that an otherwise exempt device forfeits the exemption if intended for home use, the VALID Act may effectively limit the performance of LDTs to specimens collected in a healthcare setting.

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Manufacturing Healthcare Drafting Court 72

FDA Law Blog

JANUARY 26, 2022

The Letters, and the withdrawn Draft Guidance for that matter, raise the not-so existential question about when disease awareness materials become product promotion. The Letters, and the withdrawn Draft Guidance for that matter, raise the not-so existential question about when disease awareness materials become product promotion.

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At the Lectern

AUGUST 21, 2024

Silverscreen Healthcare. preempts state statutes prescribing the procedures for paying arbitration fees and providing for forfeiture of the right to arbitrate if timely payment is not made by the party who drafted the arbitration agreement and who is required to pay such fees. The court granted review in Holland v.

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