The FDA Law Blog

JULY 6, 2023

We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here ). In fact, the priority designation for the final rule is labeled as “economically significant.” According to the Unified Agenda, the proposed rule is in the final rule stage.

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Pharmaceutical Technology

OCTOBER 31, 2022

The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date. Outlook Therapeutics president and CEO Russell Trenary said: “This BLA acceptance and PDUFA date are significant milestones in our mission to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD.

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The FDA Law Blog

OCTOBER 18, 2022

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023.

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The Checkup by Singlecare

JUNE 5, 2025

It’s approved by the Food and Drug Administration to treat Type 2 diabetes and may be prescribed off-label for weight loss. The long-term side effects of Mounjaro haven’t been well documented but may include an increased risk of gallstones. It’s injected under the skin once per week to help control blood sugar levels.

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The FDA Law Blog

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different.

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The Checkup by Singlecare

DECEMBER 28, 2023

Weight loss is an off-label , non-FDA-approved use for Ozempic. Because Ozempic is currently approved by the FDA for only diabetes management, health insurance plans are unlikely to cover the prescription medication for off-label uses such as weight loss. In fact, in clinical trials, patients taking Ozempic were able to lose 10.9%

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The Checkup by Singlecare

JUNE 6, 2025

A meta-analysis published in 2023 found that semaglutide was safe and effective for the treatment of NAFLD. Before covering Ozempic for an off-label use like fatty liver disease, your insurance company may require prior authorization. Does Ozempic help treat fatty liver disease?

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The 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. Any comments to the public notice must be submitted by August 11, 2023.

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The Checkup by Singlecare

JANUARY 3, 2024

Ozempic (semaglutide) is touted as a “miracle drug” for its ability to lower blood sugar for people with Type 2 diabetes and off-label to help people with obesity reach a healthy weight. The benefits are well-known—and well-documented in the popular press—but what about the potential downsides? Are tiredness and fatigue one of them?

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European Pharmaceutical Review

DECEMBER 20, 2023

In Q1 2023, the European Commission (EC) announced proposed changes to EU pharmaceutical legislation. In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. Internet] 2023. Internet] 2023.

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The Checkup by Singlecare

AUGUST 3, 2024

It’s also sometimes prescribed off-label to treat major depressive disorder and other mental health conditions. In 2019, the FDA approved a generic version of Latuda (lurasidone) , which just became available in 2023. This is why “ensuring patients have the proper documentation is crucial,” says Sazan Sylejmani, Pharm.D.

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The FDA Law Blog

MAY 8, 2023

a) , and related guidance documents (e.g., Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)

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The FDA Law Blog

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. In contrast , the two previous withdrawals, Makena in 2023 and Avastin in 2011, took 30 months and 11 months, respectively. On August 4, 2023, Oncopeptides submitted its appeal.

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The FDA Law Blog

FEBRUARY 28, 2023

The general structure of our submissions, and of many others that we have seen, is to have a document for each of the twenty sections and then to refer to other files, such as labeling and test reports, as attachments. Several sections of the eSTAR templates have questions that walk through related guidance documents.

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Pharmaceutical Technology

JULY 28, 2022

The TLR9 agonist is currently being investigated in the Phase III CONCLUDE trial (NCT04985968), with an expected study completion date of August 2023. This is an important population to target, as it is well-documented that a number of patients are intolerant or non-responsive to first-line biologics like infliximab or adalimumab.

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The Checkup by Singlecare

APRIL 5, 2024

That’s because the Food and Drug Administration (FDA) has approved it for Type 2 diabetes , while weight management is technically an off-label treatment. Health condition Insurance companies are much more likely to cover Ozempic when it’s prescribed for diabetes than for weight loss.

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The Checkup by Singlecare

APRIL 17, 2024

Mounjaro (tirzepatide) is an injectable medication prescribed for Type 2 diabetes mellitus, which some doctors may prescribe off-label for weight loss. Over 80 million Americans received Medicaid assistance in 2023, and it sometimes covers Mounjaro for diabetes treatment.

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Hospital Pharmacy Europe

MAY 22, 2024

In developed countries, between five and 15% patients carry a penicillin allergy label , and patients receive a penicillin allergy label by their third birthday in approximately 75% of cases. However, a large body of evidence suggests upwards of 90% of patients with a penicillin allergy label are not truly allergic.

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European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. Clin Microbiol Infect.

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ISPE

JULY 19, 2023

™ Is Gaining Momentum and Driving Innovation Trudy Patterson Wed, 07/19/2023 - 08:17 Online Exclusives July / August 2023 Pharma 4.0™ ™ Is Gaining Momentum and Driving Innovation Thomas ZIMMER, PhD 19 July 2023 The fifth Pharma 4.0™ The next important milestones for 2023 are the ISPE Pharma 4.0™ ISPE Pharma 4.0™

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pharmaphorum

MARCH 26, 2021

The GMP provisions require the EU and UK to recognise the other’s manufacturing facility inspections and accept its GMP documents. The sizeable gap in the TCA is the EU and UK’s failure to agree on mutual recognition of conformity assessments, approval bodies, product markings or labelling, other than the very limited provisions on GMP.

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The FDA Law Blog

MAY 15, 2023

States frequently review labels (and labeling) for animal food products. The CFI includes a list of common foods that “may be appropriate for use in animal food and serve as a tool for use during review of ingredients on an animal food label.” This document also describes an appeal procedure.

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The FDA Law Blog

FEBRUARY 27, 2023

That emergency declaration is set to expire on May 11, 2023. 180 days past May 11, 2023) for those telemedicine relationships established during the COVID-19 emergency. Helpful practitioner prescribing guidance is set forth in a simplified document here. 21 U.S.C. § 802(54)(D)(i). Stay tuned.

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Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. In a press release, the company said a generic launch would damage sales in FY 2023 by $300,000. Gilenya is an oral medication for multiple sclerosis.

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The Checkup by Singlecare

DECEMBER 1, 2023

Red Dye 40 is among the most commonly used artificial food dyes in the United States, and you might see it labeled under a different name on the products you consume. Regardless of what manufacturers label it as, there have been ties to specific negative side effects when ingested too frequently. FDA (2023) Is Red Dye 40 safe?

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The 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 ). On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests. By Philip Won & Allyson B.

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The FDA Law Blog

AUGUST 10, 2022

Because Jazz timely sued Avadel, the lawsuit triggered a 30-month stay, which effectively precludes final approval of the Lumryz NDA until the expiration of the patent in June 2023. Nor does FDA have the authority to look beyond the Lumryz labeling to its REMS document for a use that overlaps with the listed use code, Avadel argues.

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The 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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The FDA Law Blog

FEBRUARY 22, 2023

The only exception for a modified device is when there were no changes to: the user interface; intended device users; intended device uses; intended use environment(s); training or labeling. as a de novo special control or in a guidance document for a specific device type).

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The Checkup by Singlecare

OCTOBER 9, 2024

However, it’s shown some versatility in recent studies , so doctors might prescribe it off-label for other skin conditions that aren’t FDA approved. The issue is that many health plans won’t extend medical benefits for off-label prescriptions. Most only issue coverage for treatments approved by the FDA. How much does Dupixent cost?

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ISPE

MARCH 29, 2023

A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Features May / June 2023 A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Brown Megan E.

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The FDA Law Blog

MAY 19, 2023

Serial testing was defined as testing symptomatic individuals twice over three days with at least 48 hours between tests, which is in accordance with study findings from the National Institute of Health referenced here and current EUA labeling for serial testing. Customer Support Help line).

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ISPE

MARCH 29, 2023

A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Online Exclusives A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Brown Megan E. McMahon Timothy J.N.

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The FDA Law Blog

OCTOBER 2, 2023

The new guidance is one of three policy documents dedicated to explaining FDA’s interpretation of this statutory authority and their approach to exercising scientific judgment in evaluating drug effectiveness. We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.

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ISPE

MAY 11, 2023

Enhanced Intervention Detection in Aseptic Fill Using AI/ML Trudy Patterson Thu, 05/11/2023 - 10:32 Technical May / June 2023 Enhanced Intervention Detection in Aseptic Fill Using AI/ML Michelle Vuolo Christoph Koeth Robert J. Vials are rejected or discarded when critical zone intrusion is detected during operator interventions.

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The Checkup by Singlecare

NOVEMBER 14, 2023

Be sure to read the labels of over-the-counter sleep aids and cold medications to look for the presence of diphenhydramine before taking more. Remember, diphenhydramine comes in products by MANY names, and you don’t want to double up, so read the labels carefully. They can help review for any interactions with other drugs being taken.

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European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval.

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