Pharmaceutical Technology

OCTOBER 13, 2022

In July 2019, the MHRA held up Colonis for sending a letter to physicians advertising the off-label use of the drug in children and those with renal impairment. On 22 September, the MHRA expanded the label to include the use for sleep-onset insomnia in children with ADHD. Colonis Pharma is a subsidiary company within Clinigen.

Labelling 59

Labelling Dosage Documentation 59

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. 2019; 13(1):16-24. Clin Microbiol Infect.

Documentation 111

Documentation Labelling Hospitals 111

FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). Attachment number) and document name or description as appropriate.

Documentation 75

Documentation Packaging Communication Labelling 75

pharmaphorum

OCTOBER 4, 2022

The final guidance follows the draft CDS software guidance issued on the same date in 2019. Additionally, relevant sources should be identified and made available to the HCP user.

Documentation 105

Documentation Labelling Communication 105

Putting Patients First Blog

JULY 2, 2024

The NHC requests more clarity on how CMS will exclude QALY-based metrics and highlight when they have been removed from consideration in MFP justification documentation. Off-label usage often emerges from real- world clinical practice and patient experiences, which might not be reflected in the guidelines. Blendon, R., Casalino, L.,

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

GMPSOP

MARCH 3, 2024

Cross contamination in the pharmaceutical industry can be described as an accidental inclusion of product of another batch or unknown foreign material into a finished batch, which was not intended or not mentioned on the label. – In 2019, the FDA publicly reprimanded 21 companies for cross-contamination.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Documentation 52

PharmaTech

JUNE 6, 2025

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals.

Dosage 52

Dosage Drug Development Documentation Biosimilars 52

The Thyroid Pharmacist

DECEMBER 7, 2022

Several years ago, after reading research about all of the toxins commonly used in flame retardants (and learning about all of the many products in my home that contain these chemicals… somewhat of a shocking list), I looked at my mattress label, only to learn it contained one of the chief offenders. Labels (Furniture, Fabrics, and Carpet).

Health and Personal Care Stores 88

Health and Personal Care Stores Labelling Immunity Immunization 88

PharmD Live

FEBRUARY 17, 2022

Acute cardiac injury has been a well-documented feature of infection with SARS-CoV-2, which causes COVID-19 among patients requiring hospitalization. Effect of aspirin on coronavirus disease 2019, Medicine: July 30, 2021 – Volume 100 – Issue 30 – p e26670 Accessed Jan. Fam Med Community Health. 2021 Apr;9(2):e000741.Retrieved

Hospitals 52

Hospitals Diabetes Documentation Labelling 52

Pharma in Brief

JANUARY 9, 2022

In 2019, the federal government introduced amendments to the Patented Medicines Regulations (the Amendments ). Health Canada also consulted on proposed guidelines for the use of electronic media in prescription drug labelling (see here ). b) Continued changes to the PMPRB. The FCA also provided guidance on “inventive concept”.

Documentation 52

Documentation Labelling Vaccines Packaging 52

The Thyroid Pharmacist

JULY 29, 2022

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition. 2019;10:864.

Dosage 98

Dosage Documentation Diabetes Labelling 98

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.

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

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. vs. 398 U/mL). [1] Rev Assoc Med Bras (1992).

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunity Immunization 98

The Thyroid Pharmacist

MAY 12, 2025

25] There have also been documented cases of improved egg quality and spontaneous pregnancies following PRP, both naturally and through IVF. Vitamin D supplementation reduces thyroid peroxidase antibody levels in patients with autoimmune thyroid disease: An open-labeled randomized controlled trial. Published 2019 Apr 12.

Immunity 57

Immunity Immunization Dosage Documentation 57

FDA Law Blog: Biosimilars

MAY 13, 2025

To date, neither FDA nor HHS has issued a guidance document describing circumstances in which the agencies will consistently grant waivers, as required under FDC Act 804(j)(2). Due to the risks involved in personal importation, FDA specifically refused to implement a formal personal importation policy. 70,796, 70,800 (Dec.

Online Pharmacies 59

Online Pharmacies Drug Pricing Documentation Pharmaceutical Manufacturing 59

The Thyroid Pharmacist

NOVEMBER 8, 2024

Between 2017 and 2019, my team and I were able to collect and analyze the data from 298 GI-MAP tests. About the Samples These 298 tests were collected from my clients and participants in the Hashimoto’s Self-Management Program between 2017 and 2019. link] Published June 27, 2019. link] Published Dec 3, 2019.

Immunity 80

Immunity Immunization Diabetes Adverse Reactions 80