Eye on FDA

AUGUST 18, 2020

But it is not likely to surprise anyone that the first half of 2020 has caused not only an increase in communication from FDA, but a focus as well. Approvals – There were 54 press statements regarding approvals so far in 2020, comparing to 42 approvals announced in 2019. This compares to 114 that were issued during 2019.

Communication 61

Communication Documentation Labelling 61

European Pharmaceutical Review

OCTOBER 5, 2022

And beyond the physical limitations, those instigating industry-wide change also face pushback in the boardroom, with a recent study citing poor communication between stakeholders and rigid practices among the key barriers to more circular product packaging. 2019 [cited 2022Sep]. Consultancy.uk; 2021 [cited 2022Sep]. Overstreet K.

Packaging 98

Packaging Dosage Labelling Communication 98

Pharmaceutical Technology

NOVEMBER 30, 2022

The Health Survey for England 2019 reported that 28% of adults in the UK were obese and 36.2% 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.

Insurance Coverage and Processing 105

Insurance Coverage and Processing Diabetes Labelling Communication 105

pharmaphorum

OCTOBER 4, 2022

The final guidance follows the draft CDS software guidance issued on the same date in 2019. Software functions intended to display, analyse, or print medical information about a patient or other medical information (e.g. Additionally, relevant sources should be identified and made available to the HCP user.

Documentation 105

Documentation Labelling Communication 105

Pharmaceutical Technology

NOVEMBER 30, 2022

The Health Survey for England 2019 reported that 28% of adults in the UK were obese and 36.2% 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.

Insurance Coverage and Processing 98

Insurance Coverage and Processing Diabetes Labelling Communication 98

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.

Compounding 52

Compounding Sterile Compounds Packaging Labelling 52

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.

Documentation 75

Documentation Packaging Communication Labelling 75

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.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Compounding 52

Putting Patients First Blog

JULY 2, 2024

As noted in our previous communications, while the NHC would prefer a more traditional Notice and Comment rulemaking opportunity that would ensure the Agency directly responds to stakeholder feedback, we welcome this opportunity to express our reactions to CMS’ thinking on the negotiation program.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

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. 1 (2009): 2029.

Labelling 40

Labelling Communication Mayo Clinic 40

Pharmaceutical Technology

DECEMBER 22, 2022

However, he did point out that the joint assessment could be a useful way of narrowing down typically broad EMA label content to specific patient populations. He believed that EUnetHTA’s conclusions will most likely influence the pricing and reimbursement decision of the drug at the national level. Free Case Study.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Labelling Communication 52

pharmaphorum

FEBRUARY 5, 2021

The study was carried out at the request of the FDA, after concerns emerged about the safety of Xeljanz which emerged in 2019, and specifically a possible increased risk of blood clots in the lungs and death, particularly with the higher 10mg approved dose of the drug.

Communication 78

Communication Labelling 78

pharmaphorum

MARCH 15, 2022

The COVID-19 pandemic has radically disrupted traditional medical society conferences in a way that could scarcely have been imagined in 2019. The majority of societies reported significant increases in attendee numbers compared with those from their equivalent 2019 physical conferences. The ‘hybrid’ label is confusing.

Labelling 105

Labelling Vaccines Communication 105

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

Labelling 40

Labelling Vaccines Communication 40

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.” doi:10.1136/gutjnl-2019-318427. doi:10.1136/gutjnl-2019-318427.

Health and Personal Care Stores 105

Health and Personal Care Stores Immunity Immunization Grocery Stores 105

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).

Labelling 93

Labelling Communication Vaccines 93

The Thyroid Pharmacist

OCTOBER 6, 2023

Thus, this article was due for an update, as it was initially published in 2019. Many readers in my community report symptoms of histamine intolerance, which can be challenging to differentiate from other food sensitivities and imbalances in the digestive system. Published 2019 Mar 29. 2019; 73(1): 102-104. March 2019.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunity Immunization Dosage 98

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 101

Health and Personal Care Stores Immunity Immunization Compounding 101

European Pharmaceutical Review

SEPTEMBER 22, 2023

Since 2019, she has been Head of Vaccines and Immunoanalytical Sciences at AC Immune. Yves joined AC Immune in 2020 and is now Manager, Investor Relations and Communications. Marie Kosco-Vilbois, PhD Marie Kosco-Vilbois joined AC Immune as Chief Scientific Officer in 2019. Brain Communications.2022;4(1). Wang CY, et al.

Immunity 97

Immunity Immunization Vaccines Communication 97

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. 2019 Jun 19;:]. JAMA Psychiatry.

Dosage 122

Dosage Labelling Communication Compounding 122

pharmaphorum

FEBRUARY 26, 2021

Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. billion) hit the company in 2019. Johnson’s Baby Powder also went on sale during this year and was extremely successful. Litigation & controversy.

Vaccines 126

Vaccines Biosimilars Labelling Communication 126

PharmaShots

APRIL 3, 2023

The system offers alternative options for those patients receiving other medications The system was originally approved in 2019 for treating chronic pain.

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

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?

HIV Treatment and Prevention Agents 58

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. To date, vaginally-applied DHEA is still only available through prescription, either as Intrarosa® or an off-label customized prescription. Published 2019 Dec 17.

Dosage 98

Dosage Documentation Diabetes Labelling 98

The Thyroid Pharmacist

JANUARY 20, 2023

The first case is outlined in a 2019 report by Roberto Vita and his research team, and published in Revista da Associação Médica Brasileira. Markomanolaki and published in a 2019 issue of Journal of Molecular Biochemistry. Published 2019 Jul 22. Published 2019 Dec 9. Published 2019 Aug 15. vs. 398 U/mL). [1]

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunity Immunization 98