The FDA Law Blog

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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FDA Documentation Packaging Communication 75

Hospital Pharmacy Europe

FEBRUARY 22, 2024

Within the UK, the National Health Service Genomic Medicine Service (NHS GMS) was launched in 2018 with the aim of creating the most advanced genomic healthcare systems in the world. Their training and skills enable them to interpret and communicate complex medicines-related information to patients and other health professionals.

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Hospitals Patient Care Medical Records Dosage 111

The FDA Law Blog

FEBRUARY 27, 2023

Comment topics suggested by DEA include the following: Whether the rule should limit the issuance of prescriptions for controlled medications to FDA-approved indications contained in the labeling for those medications. The Act also established new definitions for “Internet,” “online pharmacy,” “practice of telemedicine,” among others.

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Controlled Substances FDA Documentation Communication 59

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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Health and Personal Care Stores Immunization Grocery Stores Compounding 105

The FDA Law Blog

JANUARY 4, 2023

Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. By Dara Katcher Levy — A win for patient access!

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Communication FDA Labelling Documentation 64

ISPE

MARCH 29, 2023

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

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Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

Documentation 52

Documentation Dosage Packaging Communication 52

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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Health and Personal Care Stores Immunization Dosage Compounding 98

The Checkup by Singlecare

JANUARY 23, 2024

Although it’s not officially approved for female use, some healthcare providers may prescribe it off-label for female sexual dysfunction. The FDA label for Viagra explicitly states it’s not indicated for women or children. Communicating with a partner may also help alleviate anxiety and improve intimacy. Can women take Viagra?

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Labelling FDA Communication 52

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.

Health and Personal Care Stores 99

Health and Personal Care Stores Immunization Compounding Packaging 99

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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Dosage Communication Labelling FDA 122

ISPE

MARCH 15, 2023

query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. Table 2: Organization and labeling examples for environmental sustainability issues. 33 Fixtures and fittings with a WaterSense label, can achieve a 20% reduction in indoor water use.

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Packaging Labelling Health Compliance Process Improvement 52

ISPE

MAY 10, 2023

10 April 2018. 3M explores New Label-As-A-Service Concept with Blockchain on Azure to Stop Counterfeit Pharmaceuticals.” Published 5 April 2018. You may unsubscribe from these ISPE communications at any time. “Smart Pharmaceutical Manufacturing: Ensuring End-to-End Traceability and Data Integrity in Medicine Production.”

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52

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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FDA Compounding Vaccines Hospitals 40

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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HIV Treatment and Prevention Agents Immunization Compounding Documentation 98

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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Documentation Dosage FDA Communication 98

Pharmaceutical Technology

NOVEMBER 30, 2022

A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients.

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Labelling Insurance Communication FDA 105

Pharmaceutical Technology

NOVEMBER 30, 2022

A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients.

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Labelling Insurance Communication FDA 98

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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Documentation FDA Hospitals Dosage 97

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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Communication Labelling Hospitals FDA 104