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.,

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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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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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ISPE

OCTOBER 27, 2022

iSpeak Blog. Blow-fill-seal containers are commonly used for various dosage forms, what are the latest developments in this field? Aseptic Conference Provides Solutions to Pharmaceutical Challenges. Trudy Patterson. Thu, 10/27/2022 - 06:48. Aseptic Conference Provides Solutions to Pharmaceutical Challenges. Jörg Zimmermann.

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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.

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The FDA Law Blog

NOVEMBER 29, 2022

We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). Opioid Selection and Dosage. When opioids are initiated for opioid-naïve patients with acute, subacute, or chronic pain, clinicians should prescribe the lowest effective dosage. 2022 Guideline at 15. (We 2022 Guideline at 3.

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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]

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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

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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.

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Dosage 59

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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IDStewardship

AUGUST 29, 2022

Therefore, prioritizing your assessment of patients with an imminent discharge time ( e.g. , reconciling medication discrepancies with their medications on admission and transfer; reviewing indications, efficacy, safety, dosage, and adherence of all medications prescribed) can significantly improve patient outcomes. . References.

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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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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.

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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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Digital Pharmacist

MAY 25, 2023

In this blog post, we will explore the common causes of medication errors and share seven effective strategies to enhance medication safety and best practices for reducing medication errors in the pharmacy.

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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.

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ISPE

NOVEMBER 22, 2022

iSpeak Blog. These technical topics take on new tones as the innovation of equipment changes, dosage forms change, and as the technology of the fluids and delivery systems change. Top 5 Reasons to Attend the 2023 ISPE Aseptic Conference. Trudy Patterson. Tue, 11/22/2022 - 11:50. Top 5 Reasons to Attend the 2023 ISPE Aseptic Conference.

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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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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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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.

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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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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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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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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.

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Dosage 52

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.

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Roots Analysis

MARCH 9, 2022

In addition to complexities in the manufacturing process, significant number of excipients are added in formulations and dosage forms to stabilize proteins and enhance intended properties in a biologic formulation. The post Biopharmaceutical Excipient Manufacturing Market: Current Scenario and Future Potential appeared first on Blog.

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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.

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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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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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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.

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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 (..)

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Roots Analysis

MARCH 28, 2022

Over 90% of the companies are engaged in offering services for API manufacturing, while only 53% of the companies offer the services related to final dosage form. The post Continuous Manufacturing: A Magic Bullet to Meet the Demand for Pharmaceutical Products appeared first on Blog. Our Social Media Platform. Web: [link].

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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.

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Scheduling Appointments Dosage Communication Hospitals 52

ISPE

FEBRUARY 7, 2023

For the latter two, some medications can be combined for cardiovascular treatment with less frequent dosages, which helps ensure older patients who may struggle more with maintaining a drug taking schedule receive the medications needed to manage the condition. Drug addiction prevention and oral contraception are other areas of interest.

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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.

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The Luxe Pharmacist

JANUARY 30, 2023

I reached out to Just Thrive earlier this month when I started to write this blog post to see if I could get a discount code for you all and I’m so happy that they agreed! Because Just Thrive is such a potent product, many users feel a difference in just two to three dosages. You can save 15% off everything with my code below!

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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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