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. 2021; 27 (2): S1-S21.

Documentation 111

Documentation Labelling Hospitals 111

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days. Sometimes, though, there is no clear precedent, and the product’s regulatory status falls into an undiscovered country.

Documentation 69

Documentation Labelling 69

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

FDA Law Blog: Biosimilars

MAY 8, 2023

a) , and related guidance documents (e.g., Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)

Documentation 98

Documentation Labelling 98

FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

Labelling 45

Labelling Packaging Documentation 45

pharmaphorum

FEBRUARY 25, 2021

The rare disease community has a golden opportunity to transform the way care is delivered across all four UK nations – that’s according to speakers at a parliamentary reception held to mark 2021’s Rare Disease Day.

Documentation 111

Documentation Labelling 111

pharmaphorum

MARCH 26, 2021

The GMP provisions require the EU and UK to recognise the other’s manufacturing facility inspections and accept its GMP documents. The sizeable gap in the TCA is the EU and UK’s failure to agree on mutual recognition of conformity assessments, approval bodies, product markings or labelling, other than the very limited provisions on GMP.

Documentation 119

Documentation Labelling 119

ID Stewardship

MARCH 12, 2023

Memorizing 45+ page document is certainly not a reasonable expectation, but one can certainly walk away with an awareness of general concepts and themes which are relevant. ” Labeling the use of an antibiotic as inappropriate or appropriate cannot simply be done based upon whether it is FDA-approved for a given indication.

Medication Guidelines 119

Medication Guidelines Documentation Labelling Hospitals 119

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. Melatonin is used globally as a supplement to improve sleep.

Labelling 59

Labelling Dosage Documentation 59

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. Fighting Entresto generics. 10,633,344. Free Report.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

pharmaphorum

AUGUST 31, 2021

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. Still, in 2021, we have seen the industry evolve and develop strategies on how to establish a viable ECA. Furthermore, ECAs are well-documented in the post-approval setting.

Insurance Coverage and Processing 89

Insurance Coverage and Processing Drug Development Documentation Labelling 89

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

GMPSOP

JUNE 28, 2024

Additional documents included each month. Packaging/labeling/Misbranding: 41 warnings vi. Failure to comply with regulations was the biggest (30%) reason for warning letters in 2021. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019. Checkout sample preview s.

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

On July 7, 2023, armed with these new procedures, CDER notified Oncopeptides that it proposed expedited withdrawal of Pepaxto because the postapproval study failed to verify clinical benefit and because Pepaxto was not shown to be safe or effective under its conditions of use (the documents discussed herein are published in the docket here ).

Documentation 59

Documentation Labelling Drug Development 59

Putting Patients First Blog

APRIL 7, 2025

12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier. Finally, to support transparency, reproducibility, and traceability, the FDA should require thorough documentation of AI model validation and verification.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. In September 2021, FDA released a draft guidance on Electronic Submission Template for Medical Device 510(k) Submissions (see our blog ).

Documentation 52

Documentation Labelling 52

Pharmacy Joe

SEPTEMBER 6, 2021

Don’t get me wrong – I’m not suggesting that you don’t document necessary pieces of information in the medical record, or that you don’t document your interventions. Hey, this is 2021 Pharmacy Joe again with some things to add about how to cultivate relationships with nurses as well.

Hospitals 52

Hospitals Documentation Medical Records Inpatient 52

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The absence of standards was a focal point of the Cellular, Tissue and Gene Therapies Advisory Committee Meeting in September 2021 that was convened to discuss the toxicity risks of AAV vector-based gene therapy products.

Packaging 59

Packaging Documentation Labelling Communication 59

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. Casalino, L., and Richman, B.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

Putting Patients First Blog

SEPTEMBER 3, 2024

Manufacturer-Focused Input Question 30: Off-Label Use. CMS has appropriately highlighted the significance of off- label use information, providing a specific avenue for manufacturers to submit data on off-label uses supported by evidence-based guidelines listed in CMS-recognized Part D compendia. JAMA Network Open, 6(10).

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

Putting Patients First Blog

AUGUST 21, 2023

A 2021 study found that one of the top five barriers to increasing participation of patients from historically underrepresented racial and ethnic backgrounds in clinical trials was “time and resource constraints associated with participation.” Use of CED in this manner threatens the FDA’s authority on the question of efficacy.

Documentation 40

Documentation Labelling 40

Pharma in Brief

JANUARY 9, 2022

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. The courts also had a busy year in 2021. Introduction. c) Other policy developments.

Documentation 52

Documentation Labelling Vaccines Packaging 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

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. 2021 Apr;9(2):e000741.Retrieved Effect of aspirin on coronavirus disease 2019, Medicine: July 30, 2021 – Volume 100 – Issue 30 – p e26670 Accessed Jan.

Hospitals 52

Hospitals Diabetes Documentation Labelling 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

The Thyroid Pharmacist

JULY 29, 2022

In 2021, our family moved back to sunny Los Angeles, CA, a big city far away from our home in the mountains of Colorado, but close to the beach and airport, so I was inspired to focus on a different type of outdoor air quality. For sunscreens and other over-the-counter drugs, fragrances must be identified on the label.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

Safe Biologics

MAY 10, 2024

From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”.

Biosimilars 130

Biosimilars Drug Pricing Documentation Labelling 130

FDA Law Blog: Biosimilars

JANUARY 1, 2024

Two device manufacturers received Warning Letters for QSR violations (QSR is FDA’s label for cGMP requirements applicable to medical device manufacturers). market complaints in 2021 through 2023 but could not provide documentation to demonstrate how the complaints were reviewed or evaluated. Terragene S.A.,

Documentation 59

Documentation Labelling 59

The Thyroid Pharmacist

JULY 14, 2023

Individual doctors may still be able to utilize this therapy with their patients as an “off-label” use. Remission of Hashimoto’s thyroiditis in a twelve-year-old girl with thyroid changes documented by ultrasonography. July 19, 2021. However, they are not FDA-approved for specific uses, such as thyroid health, in the U.S.

Dosage 98

Dosage Immunity Immunization Documentation 98

LifeProNow

APRIL 19, 2023

The primary endpoint evaluated in this study is progression-free survival, defined as time from randomization to the first documentation of progressive disease or death due to any cause, whichever occurs first. and Europe.” Key secondary endpoints include overall response rate and overall survival.

Adverse Reactions 100

Adverse Reactions Vaccines Immunity Immunization 100

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. 2021;35:167.

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

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In Holy Basil ( Ocimum sanctum ) The anti-inflammatory effects of holy basil (also known as tulsi) have been documented in many in vitro and in vivo studies. Published 2021 Jul 5. Oncoscience.

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. Published 2021 Mar 5. Vitamin D supplementation reduces thyroid peroxidase antibody levels in patients with autoimmune thyroid disease: An open-labeled randomized controlled trial.

Immunity 57

Immunity Immunization Dosage Documentation 57