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?

Labelling 188

Labelling 188

FDA Law Blog: Biosimilars

MARCH 5, 2024

Gaulkin & Riëtte van Laack — As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products. We’ve previously blogged about this ongoing battle here , here , here , and here. By Sophia R.

Labelling 59

Labelling 59

FDA Law Blog: Biosimilars

JUNE 2, 2025

RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. Indeed, FDA states, the existence of a certification program alone would not relieve manufacturers from their responsibilities to ensure that their labeling and distribution practices for RUO/IUO products are consistent with the products RUO/IUO label.

Labelling 64

Labelling 64

Pharmacy Joe

DECEMBER 22, 2024

This was an open label randomized trial of 110 patients who were evenly split between IV and nebulized tranexamic acid groups. These two routes of administration were compared in a randomized controlled trial for the first time recently and the results were published in the journal Chest.

Inpatient 105

Inpatient Labelling Hospitals 105

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?

Labelling 52

Labelling 52

Drug Patent Watch

FEBRUARY 19, 2025

To learn more about the role of Quality Assurance in generic drugs, check out our latest blog post: [link] So, I ask you: What do you think is the most important aspect of Quality Assurance in the generic drug industry? Share your thoughts in the comments below!

Packaging 80

Packaging Labelling 80

Drug Channels

SEPTEMBER 24, 2024

Autumn is here!

Biosimilars 52

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.

Diabetes 104

Diabetes Labelling 104

Drug Channels

SEPTEMBER 24, 2024

Autumn is here!

Biosimilars 52

Biosimilars Labelling 52

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

epicur

JULY 8, 2025

The following blog is written by Epicur Pharma’s Advisory Council member, Nicole Clausen, CSSGB, CCFP. Every prescription should have an appropriate fee that covers the cost of the veterinarian calculating the dose, determining instructions, and the technician’s time to fill and label it. Think about creating different fee tiers too.

Grocery Stores 98

Grocery Stores Medical Records Controlled Substances Compounding Pharmacies 98

FDA Law Blog: Biosimilars

JANUARY 5, 2025

We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here. Turning first to the four areas in which changes were made, the focus of two of those areas were the requirements for the required labeling statements for a product approved with an ACNU. 105288 (Dec.

Labelling 59

Labelling 59

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). The update procedures should include plans for required labeling changes and training provided to end users.

Documentation 71

Documentation Labelling Method Validation Communication 71

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.

Labelling 45

Labelling 45

RX Note

JUNE 8, 2025

Australian Medicines Handbook You will find me frequently citing the Australian Medicines Handbook throughout this blog. Only then can one have a broader and clearer overall picture. Undoubtedly, it remains my favourite drug reference (although I cannot afford the latest edition).

Compounding 40

Compounding Hospitals Patient Counseling Labelling 40

RX Note

MAY 8, 2025

Uses and off-label uses (with recommended dosage) Oral medication administration Advice to patients Essential points, including adverse drug reactions and role in therapy. Given the minimal profitability of this blog, this additional expense makes it unsustainable to distribute the app on the Google Play Store.

Health and Personal Care Stores 52

Health and Personal Care Stores Dosage Community Pharmacies Labelling 52

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

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

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.

Labelling 40

Labelling Packaging 40

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.

Drug Development 69

Drug Development Labelling 69

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

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.

Packaging 59

Packaging Labelling 59

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

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.

Compounding 97

Compounding Labelling Hospitals 97

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.

Labelling 115

Labelling Communication 115

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.

Pharmaceutical Companies 97

Pharmaceutical Companies Pharmaceutical Companies Labelling Drug Development 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.

Labelling 98

Labelling Packaging 98

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.

Labelling 98

Labelling Dosage Packaging Documentation 98

RX Note

JULY 14, 2025

Integrating Google Analytics with Blogger Follow these steps to integrate Google Analytics with your Blogger blog: Method 1: Using Google Analytics Measurement ID Go to the Google Analytics website and create a new account (if you have not already). Scroll to the Basic section and find the field labelled "Google Analytics Measurement ID."

Labelling 52

Labelling 52

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.

Communication 98

Communication Pharmaceutical Manufacturing Packaging Documentation 98

FDA Law Blog: Biosimilars

MARCH 24, 2025

If rescheduled to schedule III, marijuana businesses would be required to obtain DEA registrations, take initial and biennial inventories of marijuana on-hand, maintain transaction records, file theft and significant loss reports, and label and secure products appropriately.

Controlled Substances 71

Controlled Substances Labelling 71

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.

Labelling 59

Labelling 59

Pharmacy Joe

MAY 4, 2025

If using this off-label strategy, give preference to the preservative-free version of IV tranexamic acid due to the potential adverse effects of nebulized preservatives. There were no side effects noted in either group throughout the follow-up period. A reduced hemoptysis recurrence rate was noted at the 1-year follow-up (P =.009

Inpatient 52

Inpatient Labelling Hospitals 52

EMCrit Project

JUNE 12, 2025

EMCrit Blog. Subscribe Login Notify of new follow-up comments new replies to my comments Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* intensivist, CCRN, etc.) Δ Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* Your Job (i.e.

Labelling 96

Labelling 96

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

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.

Biosimilars 59

Biosimilars Labelling Communication 59

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.

Documentation 105

Documentation Labelling Communication 105