The FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

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The FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,

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IDStewardship

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.

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Labelling FDA 363

The Social Pharmacist

AUGUST 5, 2022

Also, guest blogging works as an attractive option. Link Actions inside a Blog Post. In your blog postings, mention the influencer. Implement Guest Posting and Blogging Activities. Just like blog commenting, guest posting and blogging boost the off-page SEO strategies for your pharmacy website.

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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

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.

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Labelling 40

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.

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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.

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Labelling FDA 45

The Social Pharmacist

AUGUST 5, 2022

Also, guest blogging works as an attractive option. Link Actions inside a Blog Post. In your blog postings, mention the influencer. Implement Guest Posting and Blogging Activities. Just like blog commenting, guest posting and blogging boost the off-page SEO strategies for your pharmacy website.

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HIPAA Customer Service Insurance Labelling 40

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.

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The FDA Law Blog

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.

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Labelling FDA 40

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.

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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.

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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.

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Labelling Customer Service Documentation 52

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.

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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).

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Labelling FDA Communication 64

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.

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Labelling 96

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.

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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.

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Labelling FDA 59

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.

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The FDA Law Blog

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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Insurance FDA Labelling 105

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).

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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.

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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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FDA Labelling Packaging Documentation 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.

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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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Labelling FDA 104

Pharma Marketing Network

AUGUST 9, 2023

In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

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Packaging Labelling Communication Pharmaceutical Companies 52

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.

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Labelling 52

The FDA Law Blog

AUGUST 4, 2022

The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. RECOGNIZE the pivotal role of labeling in the drugs and biologics approval process.

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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.

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

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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.

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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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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.

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The FDA Law Blog

FEBRUARY 16, 2023

We previously blogged on FDA’s September 2022 guidance exempting and excluding specific naloxone transactions (e.g., The “mock” carton labeling tested in the HFVS differs from the intend-to-market carton labeling. What’s next?

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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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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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