Pharmacy Times

JULY 22, 2025

By incorporating a patient's genetic profile into therapeutic decision-making, pharmacists can identify optimal drug choices and dosages while minimizing the risk of adverse events (AEs). This is particularly vital in polypharmacy scenarios, where the risk of drug-drug interactions and cumulative toxicity is high.

Compounding Pharmacies

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. You may need more or less than that based on your prescribed dosage.

Insurance

PharmTech

JULY 24, 2025

Waite further emphasizes the need for pharmaceutical companies to quickly build internal capabilities in customs compliance, including tariff classification, country of origin documentation, and accurate customs valuation. I haven't seen it yet, but there's certainly talk that, you know, that that could be the outcome here.

Dosage

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. Each year, the U.S. Apply this consistency to notation of the patients weight.

Long-Term Care Facilities

Pharmacy Times

JULY 18, 2025

Rumore, PharmD, Esq, MS, LLM, FAPhA Key Takeaways The removal of tirzepatide and semaglutide from the FDA's shortage list impacts 503A compounders, requiring adherence to complex legal and regulatory frameworks. SHOW MORE GLP-1 compounding faces legal challenges, evolving FDA rules, and heightened enforcement risks.

Compounding

Pharmaceutical Commerce

JULY 16, 2025

Compounding, by definition, involves customizing medications to meet individual patient needs, such as altering dosage forms or removing allergens. The elephant in the room: The critical absence of FDA approval The fundamental issue with compounded GLP-1s lies in their sidestepping of the rigorous FDA approval process.

Compounding

The Checkup by Singlecare

JULY 3, 2025

However, they have different FDA-approved purposes: Type 2 diabetes for Victoza and obesity management for Saxenda. The two are available in different dosages and may have different insurance coverage or prices as well. As we mentioned, these drugs are FDA-approved for different purposes. mg per day 0.6–3.0

Insurance Coverage

The Checkup by Singlecare

AUGUST 5, 2025

Eliquis is a name-brand prescription medication that’s approved by the Food and Drug Administration (FDA) to prevent stroke and embolism in people with a certain type of arrhythmia (irregular heartbeat) called atrial fibrillation (AFib) and to treat and prevent blood clots. mg, or 5 mg). Look for the formulary or drug list.

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

European Pharmaceutical Review

JULY 9, 2025

We offer end-to-end services for small molecule finished dosage forms (FDFs), including sterile and non-sterile liquids, solids, and semi-solids products. This collaborative approach enabled us to implement customised aseptic processing simulations and establish comprehensive documentation for API traceability before production began.

Documentation

PharmTech

JULY 17, 2025

Integrate regulatory standards (US Pharmacopeia, FDA bulk lists, GMP) and proactively identify risks using QRM tools. Stage 3: dosage form completion & quality evaluation Conduct rigorous physical and analytical testing; 503B batches must meet GMP-level standards. antineoplastics, allergens).

Compounding

The Checkup by Singlecare

JULY 2, 2025

Your ultimate fluorouracil cost will be affected by the dosage type and strength of the fluorouracil product you are prescribed. 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.

Insurance

The Thyroid Pharmacist

AUGUST 1, 2025

Women with treated thyroid conditions will likely need to adjust their medication dosage, perhaps multiple times. The ­ IGT and Low Milk Supply Facebook Support Group maintains a listing of galactagogues, including dosages, precautions, and additional resources. Breastfeeding is a state of enhanced thyroid hormone requirement.

Health and Personal Care Stores

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 Ozempic?

Compounding

The Checkup by Singlecare

APRIL 15, 2025

From pharmacy to pharmacy, the cost can certainly vary, but the dosage does not impact the expense significantly. The lower dosage is recommended for reduced kidney function, so your healthcare provider should help you determine your appropriate dosage. Without insurance, Paxlovid s retail price amounts to $400 per day.

Insurance

STAT

JULY 18, 2025

The FDA is set to decide whether to approve the drug, called Blenrep, as soon as next week. In briefing documents released earlier this week, FDA staff highlighted their concerns about the ocular issues and suggested lower dosages could offer patients similar efficacy in treating multiple myeloma while lowering the risk of side effects.

Dosage

STAT

JULY 17, 2025

The FDA is set to decide whether to approve the drug, called Blenrep, by as soon as next week. The agency often follows its advisers’ recommendations, but does not have to.

FDA

The Checkup by Singlecare

AUGUST 15, 2024

Severe side effects in dogs taking pantoprazole have not been documented. Pantoprazole dosage for dogs The standard pantoprazole dosage for dogs to treat stomach acid-related diseases is 0.7–1 Other published recommended dosages include: 0.5–1 The FDA has not approved pantoprazole for animals.

Dosage

The FDA Law Blog

DECEMBER 4, 2023

Unusual Amounts and Dosages Dispensing high doses of opioids in quantities far exceeding the daily morphine milligram equivalent (“MME”) dose recommended by the Centers for Disease Control and Prevention (“CDC”). The CDC has advised clinicians to carefully assess increasing total opioid dosage to greater than 50 MMEs per day).

Controlled Substances

The Checkup by Singlecare

DECEMBER 28, 2023

Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent. Weight loss is an off-label , non-FDA-approved use for Ozempic. The FDA has urged consumers to use caution when taking medication from these compound pharmacies.

Insurance

The Checkup by Singlecare

JUNE 28, 2024

It’s in a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists, approved by the Food and Drug Administration (FDA) to manage blood sugar levels in adults with Type 2 diabetes when combined with diet and exercise. Ozempic pricing will depend on your prescription dosage and pharmacy.

Insurance

The FDA Law Blog

JULY 29, 2024

Claud — There is a growing consensus among legal experts that after Loper Bright, FDA may rely on non-binding guidance to instruct industry with hopes of charting regulatory pathways that avoid litigation. The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters.

FDA

The Checkup by Singlecare

AUGUST 3, 2024

Latuda (lurasidone) is a brand-name prescription drug that’s approved by the Food and Drug Administration (FDA) to treat schizophrenia as well as bipolar depression associated with bipolar I disorder. In 2019, the FDA approved a generic version of Latuda (lurasidone) , which just became available in 2023. Apply for Medicare Extra Help.

Insurance Coverage

The Checkup by Singlecare

JULY 27, 2023

In terms of pregnancy, the Food and Drug Administration (FDA) has approved it for Category B use, which means that animal studies show that it doesn’t harm the fetus or cause abnormalities—though this determination has not been based on solid studies with humans. Can you take Dramamine while pregnant? How much Dramamine is safe for pregnancy?

Dosage

The Checkup by Singlecare

JULY 20, 2024

Food and Drug Administration ( FDA ) as a weight loss medication. As of now, phentermine is not FDA-approved for ADHD, and the evidence of its effectiveness is scarce. Phentermine is an old psychotropic medication that is indicated by the FDA for the short-term treatment of weight loss,” she says. “It

Adverse Reactions

The Checkup by Singlecare

JULY 8, 2025

Victoza and Ozempic are both brand-name injectable medications FDA-approved to treat Type 2 diabetes and lower the risk of heart attack or stroke in adults with both Type 2 diabetes and cardiovascular disease. Ozempic is also FDA-approved for kidney disease risk reduction in people with chronic kidney disease and Type 2 diabetes.

Insurance Coverage

pharmaphorum

SEPTEMBER 7, 2022

The FDA had approved the drug for use as UC treatment in the US in May 2021. The recommended initial dosage is low, with a gradual build up in dosage, so as to reduce possible side effects such as upper respiratory infection, urinary tract infection, and hypertension.

Dosage

ISPE

MARCH 16, 2023

The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. Environmental monitoring is another important aspect of Annex 1. This part of the track will include the following segments: Annex 1 overview- What is new?

Pharmaceutical Companies

The Checkup by Singlecare

FEBRUARY 23, 2024

Wegovy is a brand-name medication approved by the Food and Drug Administration (FDA) for weight loss in certain patients, including children 12 and older. To find the most accurate price, enter the correct dosage and quantity for your Wegovy prescription on the SingleCare coupon page.

Insurance

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. At the centre of the case was Gilenya’s ‘405 patent, which details methods for treating relapsing multiple sclerosis with a specific dosage of the drug.

Documentation

The FDA Law Blog

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). 50,372 at 50,372-73.

Controlled Substances

pharmaphorum

SEPTEMBER 28, 2022

Understanding these differences across diverse populations can help doctors and HCPs determine what medication and dosage best fit a patient. Food and Drug Administration (FDA). He is a recognised expert in clinical trial diversity and while at the FDA testified before Congress in support of diverse clinical research inclusion.

FDA

The Checkup by Singlecare

JUNE 9, 2024

Food and Drug Administration (FDA) that is used to control high blood sugar in adults and children one year and older with Type 1 or Type 2 diabetes. The exact dosage will depend on blood sugar (glucose) levels and the individual’s overall condition. Tresiba is a long-acting insulin approved by the U.S.

Insurance

European Pharmaceutical Review

JULY 4, 2023

There are also numerous industry guidance documents for products manufactured for use in clinical trials and guidelines, some which are specific to advanced therapeutic drug products that must be consulted. She has worked at organisations including Merck, Novartis, Schering-Plough, and Endo Pharmaceuticals.

Communication

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

Documentation

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation