FDA Law Blog: Biosimilars

MAY 19, 2025

Opioid prescriptions for high dosages and quantities, including prescriptions that individually or in combination, provide patients with daily dosages of greater than or equal to 300 Morphine Milligram Equivalents (MMEs). 81, 89, 251.

Controlled Substances 64

Controlled Substances Dosage 64

Express Pharma

JANUARY 17, 2025

As environmental concerns continue to intensify, the pressure on the pharmaceutical industry to reduce its overall environmental impact, particularly in final dosage forms, is growing proportionately.

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Dosage Pharmaceutical Manufacturing Packaging Drug Development 104

The Guardian - Pharmaceutical Industry

MAY 3, 2023

The guild says while some medicines might be widely available in certain strengths, other dosages of the same medicines are scarce, affecting 133 medicines. Sign up for Guardian Australia’s free morning and afternoon email newsletters for your daily news roundup Continue reading.

Dosage 76

Dosage 76

FDA Law Blog: Biosimilars

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.

Dosage 116

Dosage 116

Welltopia Pharmacy

APRIL 14, 2023

What is Bacopa Monnieri? Bacopa Monnieri is a plant that grows in many places such as India, Australia, Europe, Africa,

Dosage 52

Dosage 52

Welltopia Pharmacy

APRIL 14, 2023

What is Bacopa Monnieri? Bacopa Monnieri is a plant that grows in many places such as India, Australia, Europe, Africa,

Dosage 52

Dosage 52

Welltopia Pharmacy

JANUARY 28, 2023

What Is Psyllium Husk? Psyllium husk is a dietary supplement derived from the fiber-rich outer coating of the Plantago ovata plant. It is often used as a natural laxative but[.]

Dosage 52

Dosage 52

Pharmacy Joe

JANUARY 17, 2021

In this episode, I’ll discuss novel dosage forms that should not be crushed but look like they can be. Episode 575: Novel dosage forms that should not be crushed (but look like they can be) Subscribe on iTunes , Android , or Stitcher Two relatively new dosage form technologies are nanocrystals and amorphous solid dispersions.

Dosage 40

Dosage Inpatient 40

Welltopia Pharmacy

JUNE 10, 2023

Holy basil, scientifically known as Ocimum tenuiflorum or Ocimum sanctum, is an aromatic shrub belonging to the Lamiaceae basil plant family. It is native to

Dosage 52

Dosage 52

Welltopia Pharmacy

MAY 10, 2023

Overview Of Saccharomyces Boulardii Supplement? Saccharomyces boulardiiis a yeast that scientists discovered in the peels of certain tropical fruit.

Dosage 52

Dosage 52

Welltopia Pharmacy

MARCH 19, 2023

Overview Of Acetyl L-Carnitine supplement Acetyl-L-carnitine (ALC) is the derivative of the trimethylated amino acid L-carnitine (L-Carnitine burns fats into energy and transports fatty acids across the mitochondria). The ALC-transferase[.]

Dosage 52

Dosage 52

Welltopia Pharmacy

MARCH 15, 2023

Overview Of N Acetyl Cysteine N-acetyl cysteine (NAC) is a known supplement that is used for its antioxidant and mucolytic properties. It’s safe and well-tolerated. NAC is a precursor of L-cysteine,[.]

Dosage 52

Dosage 52

RX Note

JUNE 8, 2025

Australian Medicines Handbook You will find me frequently citing the Australian Medicines Handbook throughout this blog. Only then can one have a broader and clearer overall picture. Undoubtedly, it remains my favourite drug reference (although I cannot afford the latest edition).

Compounding 40

Compounding Hospitals Patient Counseling Labelling 40

FDA Law Blog: Biosimilars

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 Pharmaceutical Manufacturing Drug Pricing 59

Express Pharma

APRIL 7, 2025

Fixed-dose combinations (FDCs), which contain two or more active ingredients in a single dosage form, have seen a significant rise in production and usage across the pharmaceutical industry.

Generic Medicine 63

Generic Medicine Pharmaceutical Companies Pharmaceutical Companies Diabetes 63

FDA Law Blog: Biosimilars

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.

Dosage 59

Dosage Drug Pricing 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.

Retail Drug Stores 98

Retail Drug Stores Hospitals Doctor of Pharmacy Dosage 98

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

epicur

DECEMBER 19, 2023

The following blog is written by Epicur Pharma’s Advisory Council member Bob Murtaugh, DVM, MS, DACVIM, DACVECC. Standard Versus Exact Dosage Read the Guide! Read the Blog Previous slide Next slide My third reason is product selection and availability. Complete Product List For easy ordering of the products your patients need.

Dosage 52

Dosage Compounding 52

FDA Law Blog: Biosimilars

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

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!

Hospitals 130

Hospitals Communication Medical Records Dosage 130

RX Note

MARCH 27, 2023

Alternatively, you can start by learning the drugs listed in this blog post on their indications and common dosage. The Top 100 Drugs, 2022 published by Elsevier is a good starting point of your learning journey. As you progress in your profession, you can then begin to learn about less commonly used drugs.

Dosage 52

Dosage 52

Pharmacy Joe

OCTOBER 25, 2023

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

Dosage 52

Dosage Inpatient Packaging Documentation 52

Pharmacy Joe

JANUARY 8, 2025

Secondary outcomes were the hospital length of stay, utilization of restraints, and discharge outcomes (to a facility when admitted from home) between dosage groups. The primary outcome looked at efficacy as judged by the need for repeat doses within 4 hours. The low, medium, and high dose groups had 15, 23, and 19 patients, respectively.

Hospitals 105

Hospitals Inpatient Dosage 105

FDA Law Blog: Biosimilars

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 139

Controlled Substances Documentation Dosage Prescription Filling 139

Pharmacy Joe

MARCH 7, 2024

The authors hope that with their research and “proper patient and provider education supported by the evidence, the myth of better pain relief with “prescription-only” dosages will be debunked.” ” To access my free download area with 20 different resources to help you in your practice, go to pharmacyjoe.com/free.

Inpatient 98

Inpatient Dosage Labelling 98

FDA Law Blog: Biosimilars

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 Dosage Documentation 52

Pharmacy Joe

NOVEMBER 9, 2022

While the guideline covers many recommendations including non-opioid and non-pharmacologic recommendations, some of the most relevant ones for a hospital pharmacist helping with pain management and getting a patient on a stable regimen to be discharged revolve around selecting opioids and determining opioid dosages.

Inpatient 40

Inpatient Dosage Hospitals 40

pharmacy mentor

SEPTEMBER 2, 2024

In this blog, we will be looking at the short, medium and long term to understand what parts of pharmacy are most likely to be taken over by AI and where the human touch will still be needed going forward. Dosage Recommendations : AI tools such as Dosis can analyse patient-specific data (e.g.

Medication Therapy Management (MTM) 52

Medication Therapy Management (MTM) Customer Service Dosage Adverse Reactions 52

FDA Law Blog: Biosimilars

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.”

Biosimilars 59

Biosimilars Dosage 59

epicur

FEBRUARY 23, 2023

Our blog gives you a comprehensive look at the two. Read the Blog 3. Due to the lack of testing, particular batches may not contain the exact requested dosage needed. Download our digital or printable product lists to see all of the drugs we offer, available dosages, and the forms they’re manufactured in.

Compounding Pharmacies 52

Compounding Pharmacies Compounding Labelling Dosage 52

FDA Law Blog: Biosimilars

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

FDA Law Blog: Biosimilars

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.

Biosimilars 64

Biosimilars Dosage Documentation 64

Pharmacy Joe

JUNE 29, 2022

In this episode, I’ll discuss Paxlovid and other novel dosage forms that should not be crushed but look like they can be. Two relatively new dosage form technologies are nanocrystals and amorphous solid dispersions. Aprepitant, sirolimus, and certain forms of fenofibrate are examples of nanocrystal dosage forms.

Dosage 52

Dosage Inpatient 52

Express Pharma

JUNE 2, 2023

Counterfeit drugs, intentionally mislabeled or misrepresented, often contain substandard or harmful ingredients, incorrect dosages, or no active ingredients at all. Incidences of these fraudulent products have posed grave threats to individuals relying on medications for their well-being.

Adverse Reactions 103

Adverse Reactions Packaging Documentation Dosage 103

FDA Law Blog: Biosimilars

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.”

Labelling 104

Labelling Biosimilars Drug Pricing 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 Diabetes 52