The FDA Law Blog

JUNE 13, 2024

While the relevant regulation defines “drug product” as the “finished dosage form,” which theoretically includes the delivery device, the Court again falls back on the wording in 21 C.F.R. The Court addressed Teva’s valid argument that the Inhaler Patents are drug product patents and thus listable.

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Dosage FDA 116

The Checkup by Singlecare

DECEMBER 8, 2023

Whether you want to learn new ways to manage your anxiety , log more sleep , eat more protein , or stay adequately hydrated , you’ll find a wealth of health and wellness tips and tricks on SingleCare’s blog, The Checkup. Search for your medication, adjusting for quantity, dosage, and zip code.

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Insurance Customer Service Dosage 105

The FDA Law Blog

APRIL 16, 2024

To address concerns that manufacturers were making minor changes to drugs in order for them to be characterized as new covered outpatient drugs with updated (and higher) baseline AMPs, Congress amended the statute in 2010 to add an alternative rebate for line extensions of oral dosage form single source or innovator multiple source drugs (i.e.,

Dosage 59

Dosage 59

The FDA Law Blog

SEPTEMBER 23, 2024

For the 40th anniversary of the Orange Book (and the quasi-35th anniversary of Hatch-Waxman), we put together a public Orange Book Archive (and it has become one of the more popular stops on the FDA Law Blog). So what should we do here on the FDA Law Blog to celebrate the 40th anniversary of Hatch-Waxman? Waxman (sadly, Sen.

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FDA Dosage 59

Board Vitals - Pharmacist

JANUARY 11, 2024

The post Celebrating National Pharmacist Day appeared first on BoardVitals Blog. Retail Drug Stores or Pharmacies: Here, pharmacists dispense customer medications and answer any questions that patients may have about prescriptions, over-the-counter medications, or other health concerns.

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Retail Drug Stores Hospitals Insurance Patient Care 98

Roots Analysis

FEBRUARY 26, 2023

Principles and Strategies associated with Long-Acting Drug Delivery Lately, many technologies are being explored to develop long-acting drugs in various dosage formats, such as long-acting injectables, depot injections, implantable devices and combination products.

Dosage 52

Dosage 52

The Thyroid Pharmacist

AUGUST 23, 2023

Please note: Some people may need to increase their dosage of thiamine from 600 mg per day. It looked at the effect of thiamine on patients with Crohn’s disease and ulcerative colitis, and found that effective dosages ranged from 600 mg to 1,500 per day, depending on individual body size. [7]

Dosage 98

Dosage Labelling 98

ISPE

MARCH 9, 2023

The following CoP’s will be represented: Advanced Therapy Medicinal Products (ATMPs) Biotechnology Commissioning & Qualification Combination Products Containment Critical Utilities Disposables/Single-Use Technologies GAMP ® Investigational Products Oral Solid Dosage Pharma 4.0

Packaging 52

Packaging Dosage 52

Pharmacy Is Right For Me

APRIL 4, 2023

In addition to learning more about unique pathways on-site, you can also understand more about the career paths of these pharmacists here on our blog. And when the medication was delivered to her home, she realized the dosage no longer matched her regimen. Today we’re excited to spotlight Olufunke Sokan, PharmD!

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Hospitals Communication Medical Records Documentation 130

The FDA Law Blog

APRIL 3, 2023

In 2010, concerned that manufacturers were making minor changes to a drug merely so that it could be characterized as new covered outpatient drug with an updated baseline AMP, Congress added to the statute an alternative rebate for line extensions of oral dosage form innovator (i.e., NDA or BLA) drugs.

Dosage 59

Dosage 59

ISPE

MARCH 16, 2023

In this blog, we will briefly explore the challenges and opportunities of digitalized aseptic production, fully contained and automated production and collaborative work with CMOs. We will also address the ways in which these approaches can help to improve adherence to new Annex 1 and the overall quality and safety of pharmaceutical products.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Dosage 98

The FDA Law Blog

JUNE 27, 2024

Immediate-Release and High Dosage Opioids The government’s expert asserted that opiate prescriptions alone can create a “therapeutic duplication” red flag when two separate immediate release opioids are prescribed in their highest strength version. As for high dosage opioid prescriptions, the expert found that: Patient A.R.

Controlled Substances 52

Controlled Substances Documentation Dosage Insurance 52

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).

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Controlled Substances Documentation Prescription Filling Dosage 139

The FDA Law Blog

JANUARY 18, 2023

By Faraz Siddiqui — Last week, the Centers for Medicare & Medicaid Services (CMS) released a memorandum on how it intends to implement the Medicare Drug Price Negotiation Program, passed under the Inflation Reduction Act (IRA) (see our blog post and slide deck on IRA). The memorandum also introduced the Program’s spanking new logo.

Dosage 59

Dosage 59

The FDA Law Blog

FEBRUARY 26, 2024

314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” solid oral dosage forms),” which, FDA posits, suggests “that the terms have overlapping meanings.”

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FDA Dosage 59

The FDA Law Blog

MARCH 1, 2023

FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA staff served as pilot program observers, but also met with the contractors to provide feedback.

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FDA Dosage 45

The FDA Law Blog

JULY 31, 2023

In addition, for each partial filling whether requested by the prescriber on the prescription or during consultation with the pharmacist, the pharmacy must maintain a dispensing record of each dispensing date, name or initials of the individual dispensing, controlled substance name and dosage form, date filled, and quantity dispensed.

Controlled Substances 98

Controlled Substances Long-Term Care Facilities Dosage Communication 98

Omnicell

JANUARY 10, 2023

Ongoing outreach and consultation drives adherence Once PA is approved, the Omnicell clinical team contacts the patient to provide in-depth counseling about the medication, dosage and frequency, disease state, side effects, drug interactions, and desired outcomes for treatment. Subscribe today.

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Specialty Pharmacies Omnicell Hospitals Medication Delivery 52

The FDA Law Blog

JULY 29, 2024

Finally, the draft guidance describes the CMC information that FDA recommends applicants submit in support of a supplement for a change in dosage form or strength. That information includes adequate comparability data between the original licensed biosimilar or interchangeable and the proposed new dosage form or strength.

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FDA Dosage Documentation 64

The FDA Law Blog

APRIL 2, 2024

This proposal is clearly intended to address difficulties in formulating generic drugs with the same quantity and quality of inactive ingredients as required by regulation for certain dosage forms. “FDA FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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FDA Labelling Dosage 104

Pharma Marketing Network

DECEMBER 13, 2024

Include valuable content like case studies, dosage calculators, and patient testimonials. From blogs to webinars, its a vital tool for connecting with your audience. Embracing Digital Transformation The digital revolution has redefined pharma marketing. Websites and SEO Your website is your digital storefront.

Dosage 52

Dosage 52

The FDA Law Blog

SEPTEMBER 17, 2024

This letter, dated August 29, 2024, (at the height of the US Open, no less) comes not even a month after OPDP’s last letter from August 1, and a little over a month since another celebrity-related Untitled Letter, both of which we blogged about here.

Labelling 59

Labelling Adverse Reactions Dosage 59

The Happy PharmD

APRIL 26, 2023

I decided to calculate the dosage quickly. A 5ml dosage contains 1.8g Or maybe there might be a different dosage of what you (the resident) want. It was available at a dosage of 0.5mg/5 ml. Writing the dosage as a percentage. They would be underdosing themselves and taking the wrong dosage.

Dosage 52

Dosage Hospitals Prescription Filling Prescription Interpretation 52

Roots Analysis

FEBRUARY 27, 2023

These market developments have made modular facilities more attractive to drug manufacturers today, as these facilities can quickly switch between multiple drugs, enabling formulation and packaging in multiple formats, such as solid, liquid, semi-solid and parenteral dosage forms.

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Packaging Dosage Communication 52

Pharma Marketing Network

DECEMBER 13, 2024

Use informative blogs, FAQ sections, and case studies to improve ranking. Instagram for Patients: Use visuals to simplify complex topics, like dosage instructions or potential side effects. Search Engine Optimization (SEO) SEO is your ticket to visibility. AI-Powered Insights Artificial Intelligence can refine advertising strategies.

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Dosage Communication 52

Digital Pharmacist

FEBRUARY 12, 2024

In this blog post, we will explore the significance of medication adherence in heart health and discuss the crucial role pharmacists play in supporting patients on their journey to cardiovascular wellness. Coordinating Dosage Timing: Aligning medication schedules with the patient’s daily routine can significantly improve adherence.

Scheduling Appointments 52

Scheduling Appointments Dosage Communication Hospitals 52

Roots Analysis

FEBRUARY 15, 2023

Additionally, driven by the increase in number of BCS II and BCS IV molecules being evaluated in early phases of development, the bioavailability enhancement domain is likely to grow at CAGR of ~11%, till 2035 Further, the estimated market opportunity is expected to be well distributed across different types of drug classes, dosage forms and key geographical (..)

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Dosage 52

Digital Pharmacist

FEBRUARY 12, 2024

In this blog post, we will explore the significance of medication adherence in heart health and discuss the crucial role pharmacists play in supporting patients on their journey to cardiovascular wellness. Coordinating Dosage Timing: Aligning medication schedules with the patient’s daily routine can significantly improve adherence.

Scheduling Appointments 52

Scheduling Appointments Dosage Communication Hospitals 52

ISPE

NOVEMBER 30, 2022

iSpeak Blog. Some recent projects include upgrading a biologics manufacturing process facility and expanding manufacturing capabilities at an oral solid dosage facility. ISPE Communities of Practice Leaders – Nik Krpan. Trudy Patterson. Wed, 11/30/2022 - 11:07. ISPE Communities of Practice Leaders – Nik Krpan. Marcy Sanford.

Documentation 52

Documentation Dosage Compounding 52

The FDA Law Blog

MARCH 26, 2024

Because a “drug product” is defined by regulation as a “Finished dosage form. that contains a drug substance ,” FTC explains that “only those [patents] that claim the finished dosage form containing the drug substance of the relevant NDA” can be listed. Teva’s patents do not meet that criterion.

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FDA Dosage 59

The FDA Law Blog

SEPTEMBER 19, 2023

The closest FDA has come is in a 2003 preamble noting that patents that claim finished dosage forms—which can include “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems”—should be listed in the Orange Book, suggesting that a patent that claims both the drug substance and the delivery device should be listed.

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FDA Communication Dosage 105

Blog: Ask a Student Pharmacist

AUGUST 12, 2024

Dr. Jeong's research interests include biomarker-guided patient stratification and therapeutic efficacy inference in neurodegenerative diseases, and physiologically-based PK/PD analysis for CNS therapeutics.

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Dosage Compounding 40

The FDA Law Blog

NOVEMBER 14, 2022

Much of the guidance repeats the law and FDA’s previous notices (see e.g., our blog posts here and here ). That said, the guidance will be a helpful reference for companies that are not sure whether they are subject to the OMUFA facility fees, whether there any exceptions, how much they have to pay, when they need to pay, etc.

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FDA Packaging Labelling Dosage 52

The FDA Law Blog

MARCH 12, 2024

Each made similar points as the 3 that did delist: patents that claim the finished dosage form must be listed in the Orange Book, and the referenced patents claim the finished dosage form.

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Dosage FDA 45

ISPE

FEBRUARY 15, 2023

ISPE Launches Enabling Global Pharma Innovation: Delivering for Patients Trudy Patterson Wed, 02/15/2023 - 11:38 iSpeak Blog iSpeak ISPE Launches Enabling Global Pharma Innovation: Delivering for Patients Christopher John Potter, PhD Roger Nosal 15 February 2023 ISPE is launching a new program, Enabling Global Pharma Innovation: Delivering for Patients (..)

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FDA Dosage 95

PharmaShots

JUNE 9, 2023

Pharma companies can develop educational articles, blog posts, videos, and infographics that address the needs and challenges of their target audience. Pharma companies can create apps that provide medical information, dosage calculators, appointment reminders, and other valuable features.

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Communication Dosage 56

Board Vitals - Pharmacist

MAY 7, 2024

A typical initial regimen is oral prednisone in a daily dosage of 1 mg/kg of body weight for 8-16 weeks (or until 1 wk after remission is achieved) followed by an alternate-day single-dose and then tapered if proteinuria disappears of falls to a very low level. Corticosteroids are the initial treatment of choice.

Dosage 52

Dosage 52