Drug Topics

JUNE 11, 2025

The study cohort included 670 patients who were diagnosed with PsA of at least a 3 month duration and have active plaque psoriatic skin lesions or a documented medical history of plaque psoriasis. READ MORE: Significant Knowledge Gap Exists in Patient Awareness of Psoriatic Disease The study found that 54.2% of patients who received placebo.

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STAT

DECEMBER 30, 2024

  The new research analyzed paperwork submitted for FDA approval to market a device for 767 oximeters that had been approved between 1978-2024 and had accessible information about performance testing.

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Documentation FDA 138

STAT

JANUARY 7, 2025

The advent of the first generic GLP-1 drugs could help Medicare negotiate a lower price for the highly sought after diabetes and obesity medication semaglutide , according to experts familiar with the price-negotiation program and STAT’s review of documents from the first round of negotiations.

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Documentation Insurance FDA 125

Pharma Marketing Network

JULY 18, 2025

Smarter MLR Workflows Review cycles that once took weeks can now be accelerated by AI-based content tagging and document comparison tools. These systems highlight discrepancies between draft and approved claims, flag outdated references, and ensure language aligns with FDA guidelines. Is AI marketing safe for patient data?

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The Checkup by Singlecare

DECEMBER 6, 2024

Alcohols negative effects on the liver are well-documented. While clonidine is FDA approved to treat high blood pressure, its not considered a first-line treatment option. In rare cases, clonidine can cause liver problems, such as hepatitis and increased liver enzymes, according to its prescribing information.

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Labelling Documentation FDA 98

European Pharmaceutical Review

JUNE 12, 2025

Regulatory bodies like the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are emphasising the importance of data quality for AI applications in healthcare. The FDA’s draft guidance on AI in drug development stresses data quality as crucial for reliable AI-driven results. cited 2025Feb].

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The Checkup by Singlecare

APRIL 24, 2025

It is approved by the Food and Drug Administration (FDA) for treating Type 2 diabetes. Mounjaro is not generally covered for weight loss since its not FDA approved for weight loss. Zepbound and Mounjaro are virtually the same drug with similar dosages but different FDA-approved uses.

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Drug Topics

JULY 1, 2025

Pharmacists can get trained credentials, get up to speed and enrolled to generate $20, $30, $50 a month per patient in managing their medications a little better and documenting it.

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The Checkup by Singlecare

APRIL 4, 2025

OTC and FDA -approved prescription alternatives may be more affordable, such as OTC doxylamine succinate with pyridoxine hydrochloride and Diclegis. Documenting this trial may be required for certain prior authorizations. Is there a generic version of Bonjesta ?

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Insurance Health and Personal Care Stores Insurance Coverage Documentation 52

SingleCare

JULY 7, 2022

To prevent potential adverse events and protect public health, the FDA has implemented drug recall processes to obtain, replace, and dispose of defective, incorrectly labeled, or ineffective drugs. However, in many cases, the FDA requests or mandates that a drug is recalled.

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The Checkup by Singlecare

JULY 15, 2025

The Food and Drug Administration (FDA) may no longer approve the drug based on new safety evidence. Changes in GLP-1 insurance coverage may be due to the rising costs to health plans of the medication and the recent FDA approval of generic versions of Victoza ( liraglutide ) and Byetta ( exenatide ).

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PharmTech

JUNE 6, 2025

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals. Specifications.

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Dosage Documentation Labelling FDA 52

The Checkup by Singlecare

DECEMBER 31, 2024

Its the first prescription drug approved by the Food and Drug Administration (FDA) to prevent migraines before they strike, and clinical trials have proven its ability to reduce monthly migraine days. Thats why Aimovig (erenumab-aooe) comes as such a reassurance. That effectiveness doesnt always come cheap, though.

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Insurance Dosage Documentation FDA 52

The Checkup by Singlecare

JUNE 5, 2025

There are a few key factors that influence whether a person’s Mounjaro prescription will be covered by insurance: Condition being treated: “Insurance companies typically ask for FDA-approved indications to cover [drugs], which means Mounjaro—tirzepatide—will be typically covered for Type 2 diabetes ,” says Inna Melamed, Pharm.D. ,

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Pharmaceutical Commerce

JUNE 18, 2025

Stakeholders are aware that this federal law—enforced by the FDA and originally enacted in 2013 as a way to help bolster security and traceability of products passing through the pharma supply chain—has seen its share of delays and exemptions over the years. Next on the docket are wholesale distributors, who have until Aug.

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Specialty Pharmacies Documentation FDA 52

Pharma Marketing Network

MARCH 18, 2025

Follow FDA and Regulatory Guidelines Ensure all PPC ads adhere to FDA, EMA, or MHRA regulations. Keep Detailed Records of PPC Campaigns Document ad approvals, compliance reviews, and campaign changes to maintain transparency in case of audits. Non-compliance can lead to penalties, reputation damage, and ad disapprovals.

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Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 52

The Nontraditional Pharmacist

JULY 1, 2025

What are the regulatory constructs that the FDA puts out in front of you to get there? And then how do you develop documents to basically get approval from the FDA to study your drug in humans? There’s a lot of other aspects that go along with it, but at a high level that’s roughly what that was.

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Pharmacy Times

JUNE 9, 2025

Pulmonary function tests and provider documentation were manually reviewed to confirm asthma diagnoses, while individuals with other pulmonary diseases were excluded. 1 The study also observed that 65% of patients had a documented visit with an asthma specialist during the follow-up period.

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Compounding Pharmacies Hospitals Immunization Chemotherapy 73

The Checkup by Singlecare

JUNE 10, 2025

Formulary Every insurance plan has a long document that shows how it covers each prescription medicine, called a formulary. Aetna’s many formulary documents show that Contrave (when it’s listed) often falls under non-preferred brands. Some plans will, in fact, provide coverage. It’s all based on a few different variables.

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The Checkup by Singlecare

JUNE 5, 2025

Zepbound (tirzepatide) is a once-weekly injectable GIP/glucagon-like peptide-1 (GLP-1) receptor agonist that’s been approved by the Food and Drug Administration (FDA) to promote weight loss in adults with obesity or who are overweight with a weight-related health condition. Or, log into your health insurance portal and look at your documents.

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Pharmacy Times

JUNE 20, 2025

Other documented causes of secondary dysmenorrhea include fibroids, adenomyosis, infection, myomas, obstructive reproductive tract anomalies, and ovarian cysts About the Author Yvette C. Dysmenorrhea, also known as painful menstruation, is the most commonly reported menstrual symptom among females during the reproductive years.

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Drug Topics

JULY 7, 2025

The FDA has approved sebetralstat (Ekterly) for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age or older, according to a release from KalVista Pharmaceuticals. 1 The decision makes sebetralstat the first and only oral on demand treatment option for the condition. hours for placebo.

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The Checkup by Singlecare

JUNE 5, 2025

Mounjaro (tirzepatide) is a brand-name prescription medication that’s approved by the Food and Drug Administration (FDA) to lower blood sugar levels in people with Type 2 diabetes. However, tirzepatide, the active ingredient in Mounjaro, is an FDA-approved weight loss medication under the brand name Zepbound.

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The FDA Law Blog

FEBRUARY 2, 2025

Specifically, the change of ownership/location documents are quite a bit different and include some new and helpful information to assist applicants wading through the very confusing and cumbersome licensing process. The California Board of Pharmacy updated many of the application forms and guidelines in late 2024.

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Pharma Marketing Network

APRIL 29, 2025

Neurological Conditions Miles Levin Filmmaker who documented his battle with glioblastoma. Is influencer marketing FDA compliant? Kirsten Schultz Chronic illness advocate focusing on sexual health and disability. Marisa Zeppieri Lupus patient and founder of LupusChick.com. Why partner with chronic illness influencers?

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Documentation FDA 52

Pharmacy Times

JUNE 17, 2025

During this time frame, the pharmacy documented 152 interventions. If a discrepancy is found, the pharmacy nurses will hold the shipment, and a clinical intervention will be communicated to the provider. Results American Oncology Network (AON) Pharmacy collected data on waste and cost avoidance from February 2023 to September 2023.

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Pharmacy Times

JUNE 20, 2025

It’s also helpful to hear from managed care experts—understanding their concerns and what documentation is needed to ensure patients can get coverage for the latest treatments. I love that OPC is positioned so close to ASCO because pharmacists often can’t attend large meetings due to travel restrictions and limited funding.

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Pharmacy Times

JULY 22, 2025

This change mirrored a January 2025 FDA safety alert and label update that urged providers to consider genetic testing, inform patients of the risks, and discuss available options. link] FDA highlights importance of DPD deficiency discussions with patients prior to capecitabine or 5-FU treatment. NHS Press Release. link] Roses AD.

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Pharmacy Times

JULY 2, 2025

On February 21, 2020, the FDA approved eptinezumab-jjmr (Vyepti; Lundbeck) as the first intravenous migraine preventative treatment for adults. They can collect documentation on prior preventive therapies, baseline MMDs, and follow-up outcomes to support prior authorization, including site-of-care arrangements. News release.

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Pharmacy Times

JULY 2, 2025

Unicycive plans to resolve FDA concerns by utilizing a second manufacturing vendor with a successful regulatory history to address manufacturing-related issues. The manufacturer reported that, as part of the NDA review, they have not highlighted any technical concerns related to the submitted documentation or testing of OLC.

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PharmTech

JUNE 23, 2025

It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties. The secondary label will specify the Drug ZA-ion amount per capsule and the equivalent Drug Z-salt amount consistent with FDA labeling guidance.

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Compounding Dosage Labelling FDA 52

The Checkup by Singlecare

APRIL 15, 2025

Ozempic was initially developed to help manage Type 2 diabetes , but like Wegovy , Zepbound is FDA-approved as a weight management treatment. Since Zepbound has been FDA-approved to treat sleep apnea , its possible United Healthcare could cover the medication when treating the sleeping disorder, even if they dont cover it for weight loss.

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The Checkup by Singlecare

JULY 11, 2025

Wegovy (semaglutide) is an injectable GLP-1 (glucagon-like peptide-1) medication that was initially approved by the Food and Drug Administration (FDA) for weight loss along with lifestyle changes like diet and exercise. Like Ozempic , Wegovy has quickly risen in demand.

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Insurance Insurance Coverage Documentation FDA 52

The FDA Law Blog

OCTOBER 13, 2024

A very important aspect of the program is that it costs FDA, and the government, no additional dollars, though we do not wish to minimize the additional resources a priority review demands over the standard review that such an application might otherwise receive.

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Documentation FDA 64

Drug Topics

JULY 8, 2025

TCSs are the first-line anti-inflammatory treatment and their effectiveness and safety have been well documented.” The next step consists of treatment with topical anti-inflammatory therapies. Above all other medication classes and formulations, TCSs have been deemed as the most important pharmacotherapy in the treatment of AD.

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Pharmacy Times

JULY 1, 2025

We all share the same electronic health record and document every patient interaction in the health record, and we have very easy access to reach out to the patient's provider to let them know of any questions or concerns that the patient has regarding their medication.

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Pharmacy Times

JUNE 22, 2025

Sayer: The most documented, most significant benefits If you take a look at the trials we've run, first of all, you always see an A1c reduction, because average glucose values go down and A1c follows. Even just glucose numbers, that's way more than they've had before.

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