FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.”

Laws 105

Laws Manufacturing Drafting Technology 105

Patently O

FEBRUARY 4, 2022

In a prior post , I wrote about third party prior art submissions, but that post was only looking at issued patents. I have uploaded the listing of all the applications with third-party submissions (and current status of each application) at the link below. Dennis Crouch, Third Party Submissions , Harvard Dataverse (Feb.

Attorney 72

Attorney 72

FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). The same template can also be used for De Novo submissions. There is also a third template for Pre-Submissions for Non-In Vitro and In Vitro Diagnostic devices.

Drafting 52

Drafting Calendaring 52

FDA Law Blog

OCTOBER 5, 2022

eSTAR will be mandatory October 1, 2023 for all 510(k) submissions and subsequent supplements and amendments (e.g. eSTAR will be mandatory October 1, 2023 for all 510(k) submissions and subsequent supplements and amendments (e.g. eSTAR submissions are automated (e.g., add-to-files). add-to-files).

Drafting 45

Drafting Construction 45

Patently O

APRIL 19, 2022

If you have never tried a third-party pre-issuance submission with the USPTO or UKIPO Observation. 2] The UK law requires that any observations be in-writing and also provide reasoning. The USPTO has an online submission form in-place that is a bit clunky, but remains somewhat user friendly. by Dennis Crouch. 2, 2022). [1]

Laws 75

Laws 75

FDA Law Blog

SEPTEMBER 14, 2022

Mullen — As promised in our posts from earlier this summer ( here and here ), we are back to report on our assessment of CDRH’s electronic submission process through its Customer Collaboration Portal (CCP). Say goodbye to your thumb drives and CDs – the CCP electronic submission process couldn’t be easier. It has been seamless.

Technology 59

Technology 59

Customs & International Trade Law

DECEMBER 29, 2023

Food and Drug Administration (FDA) launched Cosmetics Direct , an electronic submission portal for product listing and facility registration required under the Modernization of Cosmetics Regulation Act (MoCRA). On December 18, 2023, the U.S. Along with the launch of the portal, the agency also released a portal user guide.

Drafting 52

Drafting Attorney Laws 52

Conflict of Laws

FEBRUARY 19, 2024

Submission timeline We welcome submissions in the form of an abstract (max. Please send your submissions via the following form: [link]. How are these regulatory shifts and the geopolitical strategy of the Union normatively legitimated? 500 words) by 15th April 2024.

Legal 76

Legal Legal Laws Diligence 76

FDA Law Blog

JULY 31, 2022

Mullen — On July 19, 2022, CDRH announced to users of its Customer Collaborations Portal (CCP) that it is now accepting premarket submissions electronically. As previously noted, this is very exciting news for the device industry, which up to this point has had to continue to ship electronic media to CDRH each time a submission is filed.

52

52

FDA Law Blog

JULY 12, 2022

Mullen — Last month, FDA announced two important steps towards accepting electronic 510(k) submissions. As discussed in our prior post on the CCP ( here ), the CCP is currently a submission tracker providing details of completed and upcoming dates. the only submission type currently trackable via the CCP). By Allyson B.

52

52

FDA Law Blog

JUNE 27, 2023

On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH. In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission.

Manufacturing 59

Manufacturing Litigation Litigating Technology 59

JURIST

SEPTEMBER 3, 2022

The court began by listening to the submissions given by the respondents, including William Ruto and IEBC chairman Wafula Chebukati, supporting the validity of the recently completed election process during which Chebukati declared Ruto the winner of the presidential contest. Lawyer Zehrabanu Janmohamed also presented her final submissions.

Lawyer 104

Lawyer Lawyers Court Drafting 104

HowAppealing

FEBRUARY 7, 2023

“DOJ says end of health emergency will terminate Title 42 policy and moot Supreme Court case; The Tuesday submission comes just a week after the administration formally announced its plan to end the public health emergency”: Myah Ward of Politico has this report.

Court 100

Court 100

FDA Law Blog

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. For example, FDA expressly notes that feedback on EUAs is outside the pre-submission process, and pre-submission meetings include videoconferences.

Drafting 45

Drafting 45

Conflict of Laws

JULY 23, 2023

The Yearbook also welcomes submissions on any topic of private international law, conflicts of laws, investor-state arbitration, and commercial arbitration. For its inaugural volume, the Yearbook has issued a call for submission : Submission Deadline: October 1st. Submission Address: helal.18@osu.edu

Laws 52

Laws Government Court Legal 52

FDA Law Blog

DECEMBER 9, 2021

Mullen — It seems like every other discussion I have these days someone asks, “what is going on with the pre-submission program?” “I heard CDRH isn’t reviewing pre-submission,” or “I heard FDA is only providing written feedback and not holding meetings.” These efforts appear designed to limit the focus of pre-submissions.

52

52

FDA Law Blog

NOVEMBER 30, 2021

Mullen — Earlier this fall, in accordance with its MDUFA IV commitments, CDRH launched an online platform that allows sponsors to track the status of its submissions. It includes all the necessary information for each submission under review including the reviewer and all relevant dates in a concise format. See announcement here.

52

52

FDA Law Blog

JUNE 7, 2022

Shuren and Maisel announced that OHT7 (formerly OIR) will now be accepting all types of pre-submissions (see announcement here ). As you’ll recall from our earlier post ( here ), OHT7 had only been accepting a limited number of non-COVID related pre-submissions since late last year and prior to that was only accepting pre?submissions

52

52

FDA Law Blog

OCTOBER 5, 2022

Mullen — It is with great excitement that we share CDRH’s announcement that now anyone may submit premarket submissions directly to the Center through the Customer Collaboration Portal (CCP). Now, according to the Center’s announcement, anyone may request access to the CCP and begin filing premarket submissions electronically.

59

59

Conflict of Laws

JUNE 15, 2023

The Australian Branch is now calling for submissions for the 2023 Brennan Essay Prize in Public International Law and the Nygh Essay Prize in Private International Law. The deadline for submission is: 15 July 2023. Written by Phoebe Winch , Secretary of International Law Association (ILA) Australian Branch.

Laws 40

Laws 40

FDA Law Blog

JUNE 5, 2022

So, what does this mean for submissions that have already received a hold letter and were counting on the additional 180 days to respond? Submissions that received a hold letter on or before the Withdrawal Date will still have the automatic extension. Not to worry.

52

52

LPB Network

JANUARY 29, 2021

Below is the call for submissions for the Southeastern Association of Law Schools Works-In-Progress series, which will occur at the 2021 SEALS Annual Conference (July 26 - August 1, Amelia Island, Florida). The deadline to submit an abstract is February.

Law School 59

Law School Laws 59

FDA Law Blog

JUNE 5, 2023

of the Format for Formulary Submissions (also known as dossiers) is on the horizon. By Dara Katcher Levy — The Academy of Managed Care Pharmacy (AMCP)’s Format Executive Committee is excited to let you know that after two years of work, version 5.0 And we need your feedback!

Manufacturing 45

Manufacturing 45

Conflict of Laws

SEPTEMBER 23, 2022

The Kim Santow Law and Social Justice Essay Prize is open to any student enrolled in an LLB or JD degree program at an Australian tertiary institution at the time of submission or within the previous six months. Essays must have been written in the 12 months before the submission deadline. pm (AEDT) on Monday 31 October, 2022.

Laws 52

Laws Law School 52

Chugh LLP

APRIL 7, 2022

If an applicant qualifies for an interview waiver or drop box submission for US visa stamping, they can now drop off interview waiver applications for free at any of the VAC drop box locations or consular offices, regardless of the applicant’s scheduled location.

Immigration 52

Immigration 52

FDA Law Blog

JANUARY 2, 2022

Lenz, Principal Medical Device Regulation Expert — On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). A Credibility Assessment Plan is suggested for inclusion in pre-submissions.

Drafting 52

Drafting Legal Legal 52

JURIST

APRIL 26, 2024

In compliance with the High Court’s mandate, the CBI established an email platform to facilitate the submission of complaints akin to those reported in Sandeshkhali. This initiative resulted in a substantial influx of submissions. However, the identities of both the accused and the victims remain undisclosed by the CBI.

Court 104

Court 104

Mondaq

DECEMBER 8, 2021

As part of our dedication to being a business that grows through its inclusion and diversity, we're pleased to have completed a new submission for the Inclusive Employers Standard.

40

40

Above The Law

MARCH 29, 2024

Send us your submission by FRIDAY, APRIL 26, at 5:00 P.M. Eastern time). The post Above The Law’s 15th Annual Law Revue Video Contest appeared first on Above the Law.

Laws 140

Laws Law School 140

FDA Law Blog

AUGUST 7, 2023

Submit proposal documents by email to ELP Proposal Submissions by September 5, 2023 at 12 PM ET. Companies may want to consider submitting a proposal so they can meet the CDRH staff who will be working with them on the review of their regulatory submissions. Identify the site visit duration.

Healthcare 40

Healthcare Manufacturing Technology 40

Patently O

JUNE 1, 2021

by Dennis Crouch. The Supreme Court has granted certiorari in the procedural copyright case of Unicolors, Inc. H&M Hennes & Mauritz. Anyone who has registered copyrights know that the Copyright Office has a set of seemingly arcane and odd rules that often arise when registering a collection or series of works.

Court 112

Court 112

Mondaq

MAY 27, 2022

Recently, the Federal Inland Revenue Service ("FIRS") issued a public notice, titled "Submission of Certificate of Acceptance" (the "Public Notice"), notifying the general public of the requirement.

40

40

FDA Law Blog

JANUARY 2, 2022

Lenz, Principal Medical Device Regulation Expert — On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). A Credibility Assessment Plan is suggested for inclusion in pre-submissions.

Drafting 40

Drafting Legal Legal 40

FDA Law Blog

NOVEMBER 22, 2021

If you’re interested in software products that do not enjoy any of the 21st Century Cures exemptions and require premarket submissions, please continue to read this blog. The most obvious update to the new draft guidance is the shift from three to two categories for determining what software documentation to include in a premarket submission.

Drafting 52

Drafting Healthcare Technology 52

ClimateChange-ClimateLaw

APRIL 19, 2024

The IACtHR received an overwhelming response to this groundbreaking initiative, with 255 amicus brief submissions pouring in from various stakeholders across the globe. The submissions underscores the necessity for tailored obligations to address the specific needs of these groups. The report is the first installment in a series.

Court 64

Court Laws Litigation Litigating 64

FDA Law Blog

SEPTEMBER 19, 2023

Specifically, the statute would be amended to require NDA sponsors to: (i) certify to the Food and Drug Administration that the information described in subparagraph (B) that is submitted to the Secretary is complete and consistent with the information such sponsor or holder provided to the United States Patent and Trademark Office and any communications (..)

Manufacturing 105

Manufacturing Statute Healthcare Litigation 105

Mondaq

DECEMBER 3, 2021

On 1 December 2021 the Cyprus Minister of Finance issued an Announcement saying that the late submission of certain direct tax returns will not carry any administrative penalties if these direct tax returns are submitted by the end of Monday 6 December 2021.

Finance 52

Finance 52