Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

Syner-G

AUGUST 9, 2022

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Working with the company’s electronic publishing vendor to ensure that fully-compiled, submission-ready documents were produced. 5 clinical study reports. and 2.7.4), and the Clinical Overview (Module 2.5).

Documentation 40

Documentation Packaging Labelling 40

European Pharmaceutical Review

DECEMBER 20, 2023

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents.

Biosimilars 98

Biosimilars Labelling Documentation 98

Eye on FDA

JULY 7, 2020

The drug in question is Schedule II drug and bears a Boxed Warning on its label, yet the link contained no risk information about the drug, despite the fact that there was present information about the benefits of the drug, according to OPDP’s letter. One of them was about the appropriate use of links.

Communication 52

Communication Documentation Labelling Pharmaceutical Companies 52

European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. 2024 [cited 2024May]. Available from: [link] Barber S.

Drug Development 103

Drug Development Biosimilars Documentation Compounding 103

The Thyroid Pharmacist

JULY 14, 2023

10] I initially wrote a guide on LLLT for my clients in my Hashimoto’s Self-Management Program in 2014, before the follow-up study was done, and was concerned that the effects wouldn’t last. Individual doctors may still be able to utilize this therapy with their patients as an “off-label” use. References [1] Nanan R, Wall JR.

Dosage 98

Dosage Immunity Immunization Documentation 98

The Thyroid Pharmacist

JULY 29, 2022

Back in 2014, I found that my Hashimoto’s flared up after using a particular lip gloss; once tested, it came back as containing arsenic! . Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, Wildfire Emissions and Particulate Matter.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Immunity 52