The FDA Law Blog

APRIL 2, 2024

Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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The Checkup by Singlecare

NOVEMBER 11, 2024

As a brand-name prescription drug, Lexapro is FDA -approved to treat major depressive disorder and anxiety disorders. Although trazodone is FDA -approved for depression, it’s primarily known for its off-label use as a sleep aid due to its sedative effects.

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Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

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The Checkup by Singlecare

NOVEMBER 9, 2023

Food and Drug Administration (FDA) just approved Zepbound (tirzepatide) for chronic weight management. The injectable medication is a new version of Eli Lilly’s Mounjaro, which is approved by the FDA to control blood sugar in people with Type 2 diabetes. Zepbound, on the other hand, has been FDA-approved for weight loss.

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The FDA Law Blog

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term. does not use this term.

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European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.

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The Checkup by Singlecare

DECEMBER 6, 2024

Because clonidine works differently than other blood pressure medications, it also has several off-label uses including anxiety, insomnia, attention deficit hyperactivity disorder (ADHD), and alcohol withdrawal. While clonidine is FDA approved to treat high blood pressure, its not considered a first-line treatment option.

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Labelling Documentation FDA 98

pharmaphorum

AUGUST 21, 2022

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. However, it has a broader label as unlike J&J’s drug it is indicated for use in previously-untreated MDD. Photo by Sydney Sims on Unsplash.

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STAT

MARCH 8, 2024

The Food and Drug Administration asks manufacturers for a list of materials before the media goes on the market, an FDA spokesperson told STAT. Companies will sometimes give clinics this information voluntarily, along with required labeling information like mouse embryo data, instructions for use, and warnings.

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Labelling FDA 119

BuzzRx

JANUARY 27, 2023

Food and Drug Administration (FDA) has to undergo several rigorous phases before approving new medications. Once the FDA approves a new drug, it means that when using this drug for an approved condition, the potential benefits outweigh the potential risks. The term “on-label use” of a drug may seem unfamiliar to most people.

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pharmaphorum

AUGUST 24, 2020

In the United States, the 21st Century Cures Act encouraged the Food and Drug Administration (FDA) to review and communicate patient experience data from trials – but the lack of a common framework for submissions and space on product labels has, until now, been something of a stumbling block. .

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Labelling Communication FDA 128

Pharmaceutical Technology

JANUARY 24, 2023

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

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pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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The FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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IDStewardship

MARCH 12, 2023

Article 9: How to Harness the Power of Social Media for Quality Drug Information in Infectious Diseases: Perspectives on Behalf of the Society of Infectious Diseases Pharmacists Find it here. This articles and the previous editions are great sources of information for what is happening in antimicrobial stewardship.

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The Checkup by Singlecare

DECEMBER 2, 2024

Pharmaceutical options such as benzodiazepines like diazepam and antidepressants like trazodone are sometimes used off-label to treat insomnia in adults. Food & Drug Administration (FDA) to treat generalized anxiety disorder. Previously sold under the brand name BuSpar, its main purpose is to alleviate symptoms of anxiety.

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pharmaphorum

JUNE 8, 2022

The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them. New atrial fibrillation feature.

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The Checkup by Singlecare

MARCH 18, 2025

Semaglutide is the active ingredient in two brand-name injectable drugs approved by the Food and Drug Administration (FDA). Ozempic is FDA approved for blood sugar control in people with Type 2 diabetes , as well as cardiovascular risk reduction in people with Type 2 diabetes and heart disease. What is tirzepatide?

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The FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). FDA also requests a “detailed description of the allegation with any available supporting documentation.”

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The Checkup by Singlecare

DECEMBER 30, 2024

Additionally, gabapentin is typically used as a human medicine; its prescribed off-label for dogs since it doesnt have FDA approval for them yet. Both vets urge dog owners to keep the medication out of reach of the petlike in a locked cabinet, for exampleand to follow the prescription label carefully.

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The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. Notably, Part 820 will look different. Revised § 820.3

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The FDA Law Blog

SEPTEMBER 29, 2022

As readers may recall, the current regulation provides for four options for a disclosure statement, i.e., text disclosure, symbol disclosure, electronic disclosure (QR code with a phone number for further information), and a text message disclosure.

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The Checkup by Singlecare

MARCH 4, 2025

Adults and pediatric patients 12 years and older Adults 17 years and older Qsymia vs. phentermine: Conditions treated Qsymia is approved by the Food and Drug Administration (FDA) for weight loss and long-term weight management in adults and pediatric patients 12 years and older with obesity. of body weight compared to 13.7%

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Digital Pharmacist

OCTOBER 24, 2022

The FDA protects public health by ensuring the efficacy and safety of human and veterinary drugs, including biological products and medical devices. It is critical for the FDA to continue to develop new advances in therapies to aid our communities in order to achieve better lives through better health. Date of Approval: 9/30/2022.

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STAT

SEPTEMBER 13, 2024

One doctor said he thinks the company wants to discourage using the drugs for unapproved purposes, a practice called off-label prescribing, which is legal and accepted in American medicine. As with company drug advertisements, social-media posts sponsored by drug makers are required by the FDA to cite the risks.

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The FDA Law Blog

AUGUST 13, 2023

The information is presented in a Q&A format. In the case of contract manufacturers, either the contract manufacturer or the person whose name appears on the label (i.e., In addition to the mandatory information to be submitted (i.e., In addition to the mandatory information to be submitted (i.e.,

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Pharma Marketing Network

MARCH 8, 2025

Pay-per-click (PPC) advertising allows brands to reach healthcare professionals (HCPs) and patients when they are actively searching for treatment options, drug information, or medical education. Optimize landing pages to ensure message consistency and compliance with FDA regulations. What platforms are best for pharma PPC campaigns?

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European Pharmaceutical Review

SEPTEMBER 27, 2022

The US Food and Drug Administration (FDA) have published initial guidance deliberating how ethical it is for children to take part in research trials. Thus, numerous drugs and medical devices approved and licensed by the FDA are missing essential paediatric-specific information on their product labels.

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The FDA Law Blog

OCTOBER 24, 2022

These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial. The sponsor and FDA reach agreement on the study design information to be publicly disclosed.

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The Checkup by Singlecare

MAY 13, 2025

It is FDA approved to help manage symptoms of asthma and improve lung function in adults and pediatric patients five years of age and older. Dulera is also prescribed off-label to help with breathing problems in adults with chronic obstructive pulmonary disorder (COPD). The post Is Dulera a steroid? appeared first on The Checkup.

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The Checkup by Singlecare

DECEMBER 12, 2024

Ozempic is also sometimes prescribed off-label (for a non-FDA-approved use) as a weight loss drug. An overview of semaglutide Novo Nordisk, the pharmaceutical company that manufactures FDA-approved semaglutide products, currently manufactures three medicines that contain semaglutide. This is the case with semaglutide.

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The Checkup by Singlecare

APRIL 17, 2025

Food and Drug Administration (FDA) for chronic weight management in adults with a starting, or baseline , body mass index ( BMI ) of 30 or more ( obesity ). You can contact your specific plan for more information about weight loss drug coverage , and specifically, Saxenda. It is approved by the U.S.

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The FDA Law Blog

MAY 8, 2023

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. See 21 CFR 807.81(a)(3)

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The FDA Law Blog

NOVEMBER 29, 2023

Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions. FDA considers these guiding principles as complimentary to their recent efforts around PCCPs including their proposed draft guidance on PCCPs.

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The Checkup by Singlecare

JULY 8, 2024

It’s also relatively new: Vraylar came on the market in 2015, and the Food and Drug Administration (FDA) has been slowly approving it for different uses since then, including a 2022 approval for use alongside antidepressants in people with major depressive disorder. Can you take Vraylar while pregnant?

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The FDA Law Blog

SEPTEMBER 22, 2024

The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ).

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The FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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