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.

FDA

Pharma Marketing Network

MARCH 18, 2025

Avoiding misleading claims or unapproved off-label promotions. 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.

Pharmaceutical Companies

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 ). 46 mg capsules $78 per 30, 7.5/46

Insurance

PharmTech

JUNE 23, 2025

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. It builds on drug calculations topics previously described (1), including guidance documents (2–5). Labeling for the primary and secondary labels are determined.

Compounding

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.

Compounding Pharmacies

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.

FDA

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. Blue Cross Blue Shield doesn’t typically cover Mounjaro for weight loss because it’s considered an off-label use of the drug.

Insurance

OctariusRx

MAY 27, 2025

Food and Drug Administration (FDA) receives more than 100,000 reports associated with a suspected medication error. Since medications are usually dosed milligrams per kilogram, learn to consistently convert and document the patients weight in kilograms. Do you know the components of a completely and properly labeled syringe?

Long-Term Care Facilities

The Checkup by Singlecare

APRIL 17, 2025

Food and Drug Administration (FDA) for chronic weight management in adults with a starting, or baseline , body mass index ( BMI ) of 30 or more ( obesity ). Your healthcare provider must submit documentation to your insurance company explaining why the drug is a medical necessity. It is approved by the U.S.

Insurance

The Checkup by Singlecare

JULY 2, 2025

Vyvanse (lisdexamfetamine dimesylate) is a prescription drug approved by the Food and Drug Administration (FDA) for ADHD in adults and children 6 years and older and for moderate to severe binge eating disorder in adults. Many Aetna plans will cover generic Vyvanse when it’s prescribed for an FDA-approved condition.

Insurance

Pharmaceutical Commerce

JULY 16, 2025

However, in the context of GLP-1s, this often means creating versions of FDA-approved drugs when those drugs are either unavailable or prohibitively expensive, raising critical questions about their regulatory oversight, safety, and effectiveness. Simply put, they bypass this standard FDA pathway.

Compounding

The Checkup by Singlecare

JULY 2, 2025

Saxenda is an injectable brand-name prescription medication that is approved by the Food and Drug Administration (FDA) for chronic weight management. If your plan requires a PA, your healthcare provider will send supporting documentation, such as your weight, lab results, and notes from your visit, to your health insurance company.

Insurance

The Checkup by Singlecare

JULY 3, 2025

However, they have different FDA-approved purposes: Type 2 diabetes for Victoza and obesity management for Saxenda. As we mentioned, these drugs are FDA-approved for different purposes. However, healthcare providers can prescribe them “off-label” for other conditions. What conditions are treated by Victoza vs. Saxenda?

Insurance Coverage

The Checkup by Singlecare

JUNE 6, 2025

Most major insurance plans, including some plans from United Healthcare and Blue Cross Blue Shield , cover Ozempic for its FDA-approved uses, such as for the treatment of Type 2 diabetes. Before covering Ozempic for an off-label use like fatty liver disease, your insurance company may require prior authorization.

Insurance

PharmTech

JULY 17, 2025

Stage 1: design the compounding blueprint Establish a complete plan including ingredients, packaging, calculations, labeling, and patient-specific factors. Integrate regulatory standards (US Pharmacopeia, FDA bulk lists, GMP) and proactively identify risks using QRM tools.

Compounding

The Checkup by Singlecare

JULY 2, 2025

Fluorouracil is sometimes used off-label, or without an FDA-approved indication, for some types of warts that have not successfully resolved with other treatments. Make sure your prescriber and pharmacist have documented the correct diagnosis.

Insurance

The Checkup by Singlecare

JULY 15, 2025

Weight loss drugs have been around since the 1930s, but they saw a recent surge in popularity after the Food and Drug Administration (FDA) approved three GLP-1 receptor agonists for weight loss: Wegovy (semaglutide), Saxenda (liraglutide), and Zepbound (tirzepatide). These are the brand names that are FDA approved to treat Type 2 diabetes.

Insurance

Pharmaceutical Technology

JULY 15, 2025

The net payment made by Sino to acquire LaNova will be approximately $500.9m, a figure that excludes the estimated cash and bank deposits, according to a company document outlining the terms of the transaction. At the time, Sino spent 142 million yuan ($19.80m) to initiate its ownership involvement with the biotech.

Packaging

The Checkup by Singlecare

MARCH 10, 2025

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Some insurance plans may cover Ozempic for managing Type 2 diabetes , which is an indication that is approved by the Food and Drug Administration (FDA) to treat. Does insurance cover compounded semaglutide?

Compounding

The Checkup by Singlecare

APRIL 15, 2025

How to get Paxlovid covered by insurance To optimize your chances of having Paxlovid covered by insurance, you will want to make sure your doctor provides a prescription and documents why it is prescribed in case prior authorization is required. Check with your healthcare provider to learn about your options. appeared first on The Checkup.

Insurance

Drug Topics

JUNE 25, 2025

image credit: syahrir / stock.adobe.com While data shows that obesity has been on the rise among children in recent history, the overall complications spurred on by childhood obesity have been well documented. of YA with obesity were prescribed OMs—predominantly GLP-1s approved for adults but used off label for younger people.

Compounding

pharmaphorum

JULY 7, 2025

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued clear guidance for incorporating RWE in regulatory submissions, labelling expansions, and post-market monitoring.

Pharmaceutical Companies

The FDA Law Blog

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). If FDA agrees to the PCCP, such changes can be made without a supplemental marketing submission.

FDA

The FDA Law Blog

MARCH 6, 2025

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. FDA notes the use of data collected outside the U.S. By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M.

FDA

The FDA Law Blog

JUNE 4, 2025

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. That leaves us to speculate what the implications of this Assessment will be.

Labelling

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.,

Documentation

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

FDA

pharmaphorum

JANUARY 20, 2022

According to the company, the defendants reportedly sold 85,247 bottles of medicine with counterfeit Gilead labelling to pharmacies over a two-year period, using falsified supply chain documentation to conceal their origin. This works to ensure the safety and efficacy of the drugs received by patients.

Documentation

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.

Labelling

Pharmaceutical Commerce

SEPTEMBER 19, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

Labelling

BioPharm

SEPTEMBER 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

Labelling

pharmaphorum

JUNE 16, 2021

With the first patient set to receive Biogen’s new Alzheimer’s drug Aduhelm in Rhode Island today, US consumer advocacy organisation Public Citizen is deeply unhappy about the FDA’s approval of the drug – and it wants the scalps of those responsible.

FDA

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Loose Ends IDEs.

FDA

The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. Notably, Part 820 will look different. The new § 820.10

FDA

The FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 820), labeling (21 C.F.R. Post-market requirements cover activities such as registration and listing (21 C.F.R.

Documentation

IDStewardship

MARCH 12, 2023

Memorizing 45+ page document is certainly not a reasonable expectation, but one can certainly walk away with an awareness of general concepts and themes which are relevant. ” 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.

Medication Guidelines