FDA Law Blog: Biosimilars

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. For labeling documents and the 510(k) summary, FDA often requests both clean and redlined versions.

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RX Note

OCTOBER 5, 2023

Such events may be related to professional practice and healthcare products, procedures and systems, including prescribing; order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

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RX Note

MARCH 23, 2023

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

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Pharmaceutical Technology

DECEMBER 4, 2022

Humira is indicated for 10 adult and pediatric conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, as per its label. Humira biosimilars became available in the EU in October 2018. Please check your email to download the Report.

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Pharmaceutical Technology

JANUARY 6, 2023

Last week, Novartis announced plans to pay $245 million to end a pay-for-delay legal battle that started in 2018. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. This settlement ends a packed year of legal rulings for the Swiss pharmaceutical giant.

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RX Note

MARCH 28, 2023

As the Code of Ethics for Pharmacists 2018 emphasizes, it is essential to engage in continuous professional development (CPD). To illustrate, every now and then, I may encounter an off-label indication of medication that I do not know of. Nevertheless, I still miss my free lunch, and free pens much.

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Putting Patients First Blog

DECEMBER 5, 2024

Real-world case studies demonstrating how PPI has influenced decisions, such as targeted approvals or label modifications, would clarify its practical utility. 17 In addition to its role in pre-market decisions, PPI can be valuable in post-market activities, including the formulation and communication of recall notices. Viera, Nancy D.

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European Pharmaceutical Review

NOVEMBER 24, 2022

These include Meditag serialised hologram labels, first introduced in 2005 and found on all registered medicines in Malaysia to help pharmacists and inspectors detect unauthorised and counterfeit product. The fourth version was introduced in 2018. An expansive role for holograms… Meditag serialised hologram labels.

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pharmaphorum

OCTOBER 7, 2021

Rewind to March of 2020, and pharma companies were facing a communication crisis. A 2018 survey by Ashfield Healthcare found, for example, that 78% of HCPs have shown a preference for a mix of online and physical events. The crisis that changed everything.

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The Thyroid Pharmacist

OCTOBER 6, 2023

Check food labels carefully, and be extra careful if you are eating out, as it’s difficult to know all of the ingredients used in restaurants. A 2018 study showed elevated levels of zonulin and dysbiosis (bacterial imbalances in the gut) in people with histamine intolerance. [28] Published 2018 Nov 25. Published 2018 Aug 27.

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Eye on FDA

JULY 19, 2021

Also by mid-year last year, FDA announced 55 approvals, including several Emergency Use Authorization (EUA) announcements for drugs and devices compared to just 44 approvals, EUA’s, or label expansions so far this year ( though the number of new molecular entities is running at a very high pace during the first half of this year).

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The Thyroid Pharmacist

OCTOBER 28, 2022

Dose: While the label of the product recommends taking two capsules per day, I used higher doses, building up to four capsules, three times per day. The probiotic has been so successful in inducing remission, it has been labeled as a “medical food.” Published 2018 Oct 29. Published 2018 Jul 17. Published 2018 Jul 10.

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The Thyroid Pharmacist

OCTOBER 27, 2023

These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Precautions Do not take more than the recommended dose on the label. Humic extract, the main ingredient, contains fulvate, which helps the cells in our gut better communicate with each other and bacteria.

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The Thyroid Pharmacist

JANUARY 6, 2023

It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression. Published 2018 May 9. Shapiro, F.

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PharmaShots

APRIL 3, 2023

It now offers DPN patients relief from chronic pain through low doses of stimulation & the battery lasts up to 10 years at low-dose settings The system also pairs with Abbott’s NeuroSphere Virtual Clinic, a connected care app for people to communicate with a physician and receive remote treatment adjustments. The authorization incl.

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RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night. Human Touch - Why Artificial Intelligence cannot replace us still? Theory in Practice - Life is not ideal but a struggle Life - Why?

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

The Thyroid Pharmacist

FEBRUARY 10, 2023

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. In a 2018 poll conducted by researchers from the University of Michigan, only 17 percent of adults above age 65-80 said they had discussed their sex life with their doctor! [24]

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The Thyroid Pharmacist

JANUARY 20, 2023

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In Published 2018 Dec 9. doi:10.1155/2018/8198652 [47] Dun Y, Liu S, Zhang W, Xie M, Qiu L. However, as with all substances, they can affect each individual differently. Oxid Med Cell Longev.

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