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

NF2 BioSolutions

JANUARY 4, 2023

Print our cake labels, bunting and flyers to make your event a great success. — This blog has been created as a way to share stories, ideas, positivity and even sprinkle in some science. Everyone is welcome here and warmly encouraged to join us in contributing to our community through this blog.

Labelling 96

Labelling 96

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.

Labelling 104

Labelling FDA 104

The FDA Law Blog

SEPTEMBER 29, 2022

The Court remanded to USDA, the BE labeling regulation provisions regarding these disclosure options without vacatur; in other words, the status quo is maintained (products using these disclosure options need not be revised immediately) while USDA revisits these two disclosure provisions of the BE labeling rule.

Labelling 59

Labelling Packaging 59

The Social Pharmacist

JULY 28, 2022

So, it ensures that you always have a steady stream of content posted as evergreen content, such as blog posts, podcasts, and videos. . Labeling systems. If your company’s content calendar has a rainbow of colorful labels, translate your organizational system to your scheduling tool. Key Features.

Labelling 52

Labelling Customer Service Community Pharmacies Documentation 52

The Social Pharmacist

JULY 28, 2022

So, it ensures that you always have a steady stream of content posted as evergreen content, such as blog posts, podcasts, and videos. . Labeling systems. If your company’s content calendar has a rainbow of colorful labels, translate your organizational system to your scheduling tool. Key Features.

Labelling 52

Labelling Customer Service Documentation 52

The Social Pharmacist

JULY 28, 2022

So, it ensures that you always have a steady stream of content posted as evergreen content, such as blog posts, podcasts, and videos. . Labeling systems. If your company’s content calendar has a rainbow of colorful labels, translate your organizational system to your scheduling tool. Key Features.

Labelling 52

Labelling Customer Service Documentation 52

IDStewardship

MARCH 12, 2023

” Labeling the use of an antibiotic as inappropriate or appropriate cannot simply be done based upon whether it is FDA-approved for a given indication. This blog post I did may also be of interest, on the topic. Daptomycin: from the mountain to the clinic, with essential help from Francis Tally, MD Find it here.

Medication Guidelines 299

Medication Guidelines Documentation Labelling Hospitals 299

The Social Pharmacist

AUGUST 23, 2022

This blog discusses the nature of backlinks and the background for each quality backlinks necessary for your pharmacy website’s SEO performance. Links in a blog post stand out, and some people hover over them before they even read the post. So, backlinks allow you to reach people who may not otherwise be aware of your business or blog.

Labelling 40

Labelling 40

Roots Analysis

SEPTEMBER 13, 2023

The conjugation of biomolecules is also referred to as biomolecule labeling when the modification with conjugates lead to detection ( direct / indirect ) for bioimaging and immunoassays. The below figure highlights the different types of molecular conjugates and labels that can be conjugated with various molecules.

Labelling 40

Labelling 40

The FDA Law Blog

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 FDA 45

The FDA Law Blog

SEPTEMBER 15, 2022

Interestingly, in the 2019 proposal for sunscreen labeling, FDA proposed to require a size at least one quarter the size of the most prominent printed matter). Draft Guidance on the Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products.

Labelling 45

Labelling FDA 45

The FDA Law Blog

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 FDA Communication 64

The FDA Law Blog

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.

FDA 69

FDA Labelling 69

The FDA Law Blog

DECEMBER 22, 2022

The Court agreed with the Petitioners, holding that banning the use of the device would regulate the practice of medicine or prohibit the off-label use of a device. In other words, Congress is proposing to let FDA ban devices for particular uses, including off-label uses. At first blush, this might not seem like such a big deal.

FDA 114

FDA Labelling 114

The FDA Law Blog

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 FDA 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

The FDA Law Blog

SEPTEMBER 23, 2022

For a number of years, FDA has been including groups of related preferred terms in tables in the Adverse Reactions Section of drug labeling (Section 6), generally describing such groupings with the use of footnotes. Such groupings have generally seemed to appear in labeling on an ad hoc basis, without standardization.

Labelling 52

Labelling Adverse Reactions FDA 52

The FDA Law Blog

DECEMBER 15, 2022

Further, petitioners [sought] recognition by FDA that homeopathic drugs, properly manufactured and labeled, and evaluated by appropriate standards, do not meet the legal definition of “new drugs,” and therefore are not subject to premarket review other than satisfying the requirements of current or likely inclusion in the HPUS.

FDA 98

FDA Labelling 98

The FDA Law Blog

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.

FDA 104

FDA Labelling Dosage 104

The FDA Law Blog

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 FDA 59

The FDA Law Blog

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 FDA 59

The FDA Law Blog

AUGUST 23, 2022

Instead of simply denying authorization, FDA responded by authorizing these tests with a requirement in the labeling for serial testing. For example, labeling stated: This test is authorized “when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.”.

Labelling 97

Labelling Communication FDA Medical Schools 97

The FDA Law Blog

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.

FDA 98

FDA Labelling Packaging 98

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 FDA Hospitals 97

The FDA Law Blog

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.

FDA 59

FDA Labelling 59

The FDA Law Blog

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.

FDA 115

FDA Communication Labelling 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.

FDA 97

FDA Pharmaceutical Companies Pharmaceutical Companies Labelling 97

The FDA Law Blog

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.

Labelling 59

Labelling Communication FDA 59

The FDA Law Blog

JANUARY 2, 2023

Labeling in the drug and biologics approval process. Save 10% with the FDA Law Blog promo code: D10-999-FDALAWBLOG. The essentials of the approval process for drugs and biologics. The role of the Hatch-Waxman Act in the patenting of drugs and biologics. Clinical trials for drugs and biologics.

FDA 59

FDA Labelling 59

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 Packaging Documentation Pharmaceutical Companies 98

NF2 BioSolutions

JULY 5, 2022

Cake/plant/etc label template. * — This blog has been created as a way to share stories, ideas, positivity and even sprinkle in some science. Everyone is welcome here and warmly encouraged to join us in contributing to our community through this blog. Need a fundraising kit? Make your own bunting. Blank sponsorship form.

Labelling 52

Labelling 52

The FDA Law Blog

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).

Labelling 59

Labelling FDA Controlled Substances 59

The FDA Law Blog

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.

FDA 105

FDA Documentation Labelling Communication 105

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.

FDA 59

FDA Labelling Packaging Documentation 59

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 ). As we discussed in our prior blog post, there needs to be a better way to understand the outcome of FDA’s review.

FDA 59

FDA Documentation Labelling Communication 59

The FDA Law Blog

OCTOBER 26, 2022

to take photographs as necessary; to collect samples; talk to pertinent staff; or to collect food labels and labeling). As we’ve discussed in prior blog postings, FDA has already trod this path with respect to foreign drug establishments that allegedly prevented the taking of photographs. See here and here.

FDA 59

FDA Labelling Documentation 59