ALiEM - Pharm Pearls

JULY 20, 2023

6 blog posts met our standard of online excellence and were approved for residency training by the AIR Series Board. More specifically, we identified 1 AIR and 5 Honorable Mentions. Take the AIR Infectious Disease Module at ALiEMU Interested in taking the AIR quiz for fun or asynchronous (Individualized Interactive Instruction) credit?

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Labelling 188

ID Stewardship

OCTOBER 27, 2022

Well this blog post is not nearly as cool as that show, but it may be a fun read at least! Here is a fun blog post to help memorize some antibiotic toxicities – from A to Z. Here is a helpful blog post on considerations for going from IV to PO with antibiotics. Myth 9: Penicillin allergy labels are not a big deal.

Labelling 145

Labelling 145

pharmaphorum

NOVEMBER 17, 2021

BRINGING IT ALL HOME: HOW LABEL MANAGEMENT SOLUTIONS. In this blog, PRISYM ID’s Clinical Trials Sales Manager Bob Bowdish looks at the challenges of in-sourcing label management processes for CDMOs, and explores how they can be overcome by investing in a cloud-based, validation-ready labeling solution. Stick or twist?

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Labelling 52

Drug Channels

SEPTEMBER 24, 2024

Autumn is here!

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Biosimilars Labelling 52

Pharma Marketing Network

OCTOBER 22, 2020

Accordingly, if a company is promoting a drug for catatonic schizophrenia, but the product is only approved for disorganized schizophrenia, such promotion could cause patients and clinicians to believe that the product is approved for an off label disease. Third-Party, Independent Blog. Independent blogs raise other issues.

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Diabetes Labelling 104

Drug Channels

SEPTEMBER 24, 2024

Autumn is here!

Biosimilars 52

Biosimilars Labelling 52

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

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Labelling Vaccines Communication 40

FDA Law Blog: Biosimilars

MARCH 29, 2023

Emergent will need time to manufacture and distribute NNS with the new OTC labeling, so the public should not expect to be able to walk into their local pharmacy and grab a box off the shelf in the coming days. When OTC NNS will become commercially available is ultimately determined by the sponsor of the drug—Emergent BioSolutions.

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Labelling 105

ALiEM - Pharm Pearls

MARCH 1, 2023

4 blog posts met our standard of online excellence and were approved for residency training by the AIR Series Board. More specifically, we identified 1 AIR and 3 Honorable Mentions. Please go to the above link. You will need to create a free, 1-time login account.

Labelling 130

Labelling 130

FDA Law Blog: Biosimilars

NOVEMBER 14, 2024

More recently, the agency invested significant efforts in modernizing nutrition labeling requirements and implementing a sodium reduction initiative. Whatever the worth of those recommendations may have been, the fact is that the prevalence of obesity has significantly increased in the intervening years.

Labelling 64

Labelling Diabetes 64

FDA Law Blog: Biosimilars

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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Labelling 45

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP).

Labelling 64

Labelling Communication 64

FDA Law Blog: Biosimilars

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling.

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Labelling Packaging 40

Digital Pharmacist

OCTOBER 11, 2023

In this blog, we’ll explore several ways pharmacies can get involved in this important initiative. These events can cover various topics, such as understanding prescription labels, proper medication use, managing chronic conditions, and reading nutritional labels. Still need ideas?

Health and Personal Care Stores 20

Health and Personal Care Stores Communication Labelling 20

FDA Law Blog: Biosimilars

MAY 23, 2023

We previously noted that “ the skinny label may be dead ” and, while we still can’t be sure if it’s truly gone (but not forgotten), we now know that the Supreme Court won’t hear this case at this time. So, while the skinny label may not actually be dead, there will certainly be a reluctance to use it.

Labelling 40

Labelling 40

Pharmacy Is Right For Me

OCTOBER 21, 2022

In addition to learning more about unique pathways on our new webpage, we’ll also be featuring pharmacists who work in these unique settings on our blog. My evenings involve music production, radio show production, podcast production, reviewing new music sent by labels/music promoters, and preparing for gigs.

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Hospitals Labelling Vaccines Drug Development 130

FDA Law Blog: Biosimilars

APRIL 2, 2024

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

Labelling 104

Labelling Biosimilars Drug Pricing Dosage 104

FDA Law Blog: Biosimilars

NOVEMBER 13, 2023

Program highlights include: Spotlight on FDA’s Newly Proposed ACNU Rule Updates on Monograph Reform Implementation Advertising, Labeling and Claims Substantiation Essentials Exploring the Recent Wave of Rx-OTC Drug Switches Hyman, Phelps & McNamara, P.C. FDA Law Blog readers can save 10% with the following promo code: D10-999-FDA24.

Labelling 59

Labelling 59

FDA Law Blog: Biosimilars

JULY 22, 2024

FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ). s John W.M. Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” You can register for the conference here.

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Packaging Labelling 59

FDA Law Blog: Biosimilars

NOVEMBER 10, 2024

The rest of this blog will focus on the Clinical Trials Grants Program. These studies are crucial because understanding the natural course of a disease helps in designing better clinical trials and defining meaningful endpoints for future drug development.

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Drug Development Labelling 69

The Honest Apothecary

APRIL 24, 2023

Here I share some of the latest news, articles, editorials, or blog posts that fall generally under the theme of Pharma or healthcare. A condition known as “Opioid Induced Hyperalgesia” or OHA has been reported enough times now that the FDA is requiring an update to all the labeling of all opioids to reflect this potential risk.

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Compounding Labelling Hospitals 97

FDA Law Blog: Biosimilars

JUNE 26, 2024

eSTAR Templates As we have previously explained in our blog post here , eSTAR is an interactive PDF form designed to assist users in creating “complete” submissions. package labeling is optional). It includes questions about the product, that when answered, reveal additional information that should be supplied with a submission.

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Labelling Packaging 98

FDA Law Blog: Biosimilars

MARCH 23, 2025

Additionally, FDAs interpretation of a clinically meaningful difference between a prescription drug and a nonprescription drug when the only difference is the existence of an ACNU raises interesting legal issues that may merit additional fleshing out.

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Labelling 59

FDA Law Blog: Biosimilars

AUGUST 7, 2024

But recently, a new challenge was filed in the District Court for the District of Columbia questioning whether modifications to labeling as a result of patent protections—beyond the mere omission of language—are permissible under the section viii carve-out requirements. FDA and intervenor MSN vehemently defend FDA’s approval here.

Labelling 59

Labelling Hospitals 59

FDA Law Blog: Biosimilars

NOVEMBER 29, 2023

See our prior blog post on the topic here. Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions.

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Labelling Communication 115

FDA Law Blog: Biosimilars

APRIL 25, 2024

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. Comments to the revised draft guidance are due to the docket by June 25, 2024.

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Biosimilars Labelling Communication 59

Express Pharma

APRIL 6, 2023

This can include everything from product testing and labelling to marketing and advertising requirements. Challenge 4: Quality control and safety concerns Nutraceutical startups must ensure that their products meet quality and safety standards, as well as comply with labelling and advertising regulations.

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Labelling Dosage Packaging Documentation 98

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. However, in recent years, there has been a noticeable decline in the number of these letters being issued.

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Pharmaceutical Companies Pharmaceutical Companies Labelling Drug Development 97

Eye on FDA

JULY 19, 2021

It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. It is not always an easy task because the nature of FDA’s practice in this respect has evolved over time. Apologies for the misfire, but hopefully we are working more smoothly now.

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Labelling Communication Vaccines 93

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. of the total expenditures for all Part D drugs in 2021. 1395w-114c(e).

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Labelling Drug Pricing Compounding Payment Processing 105

RX Note

JULY 18, 2024

On the other hand, Google Blogger focuses on sharing the writer's thoughts and ideas through frequently updated blog posts. In contrast, a typical Google Blogger homepage displays recently published blog posts. Blogger features a simpler webpage design , with a standardized theme and layout , all to focus on writing blog posts.

Labelling 40

Labelling 40

pharmaphorum

OCTOBER 27, 2022

Blogs – A company is free to own a blog or engage a blog writer by way of sponsorship or consultancy fees. In the EU and UK, where direct-to-consumer promotion of POMs is prohibited, companies may not sponsor blogs that promote, or could reasonably be expected to promote, such products.

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Communication Pharmaceutical Manufacturing Packaging Documentation 98

FDA Law Blog: Biosimilars

APRIL 21, 2024

Karst — If you’ve been following this blog since the early days, then you know we fervently followed the more-than-decade-long soap opera that was The Medicines Company’s efforts to obtain a Patent Term Extension (“PTE”) from the U.S. It’s not terribly uncommon for FDA to issue corrected approval letters (and corrected labeling).

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Labelling Controlled Substances 59

RX Note

MAY 23, 2023

Introduction A visually appearing and user-friendly theme is essential for attracting and engaing readers on your blog. Do not hesitate to experiment with different combinations until you achieve the desired look for your blog. Customizing Blogger Theme Blogger provides a variety of free themes to choose from.

Labelling 40

Labelling 40

RX Note

MAY 4, 2023

Introduction Blogger is a popular platform for creating and publishing blogs. Summary Hopefully, with these tools and tips, you can write great blog posts smoothly.in Use themes to change how your blog looks In this article, I will share some of the insights that I have gained from writing in Blogger for years.

Labelling 52

Labelling 52

FDA Law Blog: Biosimilars

APRIL 25, 2023

We have recently blogged on this topic (“ Is my software a medical device? ”). Users of eSTAR templates need to add attachments for cybersecurity risk management, cybersecurity management plan, continuing support plan, and cybersecurity labeling. Loose Ends IDEs.

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Documentation Labelling Communication 105

FDA Law Blog: Biosimilars

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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Labelling Packaging Documentation 59