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

GMPSOP

AUGUST 11, 2024

To maintain the integrity and safety of these investigational products, you must adhere to Good Manufacturing Practice (GMP), FDA Clinical Trail Guidance Documents , and relevant ISO or EN standards. Additional documents included each month. Additional documents included each month. ensure traceability and compliance.

Packaging 52

Packaging Documentation Labelling Dosage 52

GMPSOP

MARCH 30, 2024

Line clearance ensures the processing line is free of any irrelevant products, components, and documentation that could be left accidentally from an earlier batch. Line opening ensures correct products, components, and documentation are brought into the processing line so the operation can commence without error.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Big Molecule Watch

MAY 3, 2024

The guidance remains in draft form and, as with any FDA guidance document, it is not legally binding and, when final, will reflect FDA’s “current thinking” on this topic.

Biosimilars 49

Biosimilars Communication Labelling Documentation 49

Pharmacy Joe

MAY 1, 2024

Subscribe on iTunes , Android , or Stitcher The label of “penicillin allergic” usually sticks to a patient’s medical record forever. The documented allergy was severe in nature for 13% of patients, moderate for 43%, and unknown for 44%.

Inpatient 98

Inpatient Medical Records Documentation Labelling 98

Pharma Marketing Network

MARCH 18, 2025

However, pay per click advertising (PPC) presents a powerful and targeted solution for pharma marketers looking to engage HCPs efficiently. Avoiding misleading claims or unapproved off-label promotions. But how can pharma marketing teams maximize the impact of PPC campaigns while ensuring compliance and generating high-value leads?

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation Labelling 52

pharmaphorum

MARCH 2, 2021

The data must be quickly documented and reported to public health agencies to ensure effective record keeping, equal access to the vaccine and patient safety. After collecting the information, they print a plastic barcode label that can send the recipient’s vaccination records to the cloud with a simple scan. Vaccine supply levels.

Vaccines 119

Vaccines Adverse Reactions Documentation Labelling 119

FDA Law Blog: Biosimilars

JUNE 27, 2023

FDA also requests a “detailed description of the allegation with any available supporting documentation.” In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission. We hope the status is more than just an “Under Review” label.

Documentation 59

Documentation Labelling Communication 59

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

Alternatively, the company can present a justification for not being regulated and receive a free informal determination by sending an email to DeviceDetermination@fda.hhs.gov. Sometimes, though, there is no clear precedent, and the product’s regulatory status falls into an undiscovered country.

Documentation 69

Documentation Labelling 69

pharmaphorum

DECEMBER 30, 2022

The report also finds that the joint briefing document presented to the advisory committee did not adequately represent differing views within the FDA on Aduhelm. Moreover, additional informal meetings, telephone calls and emails were undocumented – contravening FDA’s internal recording policies.

Documentation 59

Documentation Labelling 59

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

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. When referencing documents within the AI response, cite location within the 510(k) supplement (e.g.,

Documentation 75

Documentation Packaging Communication Labelling 75

pharmaphorum

OCTOBER 4, 2022

4) intended for the purpose of enabling such HCPs to independently review the basis for such recommendations that such software presents, so that it is not the intent that such HCPs rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient (Criterion 4). Criterion 3.

Documentation 105

Documentation Labelling Communication 105

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

GMPSOP

MAY 31, 2024

A validation master plan (VMP) is a strategic document that identifies the elements to validate, the approach to each element, organizational responsibilities, and a strategy for maintaining validation documentation. – General guidance for validation document format. Additional documents included each month.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

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. Beyond the FDA, other institutions have documented what industry standards should look like in assessing RWD in a regulatory context. Furthermore, ECAs are well-documented in the post-approval setting.

Insurance Coverage and Processing 89

Insurance Coverage and Processing Drug Development Documentation Labelling 89

Pharmacy Joe

FEBRUARY 26, 2025

In this episode, I’ll discuss oral sedation strategies for young patients presenting to the ED with acute severe behavioral disturbance. The study was an open-label, multicenter, randomized controlled trial in 9 Australian Emergency Departments.

Hospitals 52

Hospitals Inpatient Documentation Labelling 52

ID Stewardship

MARCH 12, 2023

Side note, I also have learners watch this video from CIDRAP-ASP which is a presentation by Brad Spellberg. 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.

Medication Guidelines 119

Medication Guidelines Documentation Labelling Hospitals 119

Viseven

JULY 25, 2024

billion for the illegal marketing of four of its off-label drugs, which became one of the biggest fraud settlements in the healthcare industry. This includes verifying the evidence presented, the research results, and even the factual information. For example, Pfizer was fined $2.3

Documentation 52

Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

GMPSOP

FEBRUARY 25, 2023

Finished product samples are drowned from packed products to check if the labels are applied correctly, batch number and expiry dates are correct and legible. You will also check printed labels that are affixed on primary containers display correct information (e.g., Additional documents included each month.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Eye on FDA

JULY 7, 2020

This year the unprecedented circumstances presented by the COVID-19 pandemic make it particularly interesting this year. The agency had never said that this was not a permitted practice and only made it clear by issuing the letters, rather than having enunciated the parameter through a guidance document about digital communications.

Communication 52

Communication Documentation Labelling Pharmaceutical Companies 52

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintain documentation. All documentation must be kept as supporting evidence. Additional documents included each month. Additional documents included each month. Subscribe a.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintaining documentation. All documentation must be kept as supporting evidence. Additional documents included each month. Additional documents included each month. Subscribe a.

Documentation 52

Documentation Packaging Communication Customer Service 52

Putting Patients First Blog

APRIL 7, 2025

AI in Drug Discovery and Preclinical Development The integration of AI and ML into drug and biologic development presents transformative opportunities while introducing critical regulatory and ethical challenges. 3 ,4 The NHC is uniquely positioned to provide input on this issue.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. – Document control records management and archiving systems. Additional documents included each month. All written and updated by GMP experts.

Documentation 52

Documentation Method Validation Packaging Data Entry 52

GMPSOP

DECEMBER 6, 2024

All waste generated during the cleanup should be disposed of properly in labeled bags, and the equipment used must be cleaned and stored appropriately. Additional documents included each month. Examples include oil leaks from equipment in a packaging line or small solvent spills in the printing and labeling machine.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Documentation Packaging 52

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

GMPSOP

MARCH 17, 2023

Additional documents included each month. As a preventive action, the supplier of the carton was contacted and presented the issue. – Status control: implementing status labels to clearly identify workflow status such as issues, returns, rejects and reworks of components to prevent mix ups. Checkout sample preview s.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 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. It includes questions, text, logic, and prompts, and integrates databases such as FDA product codes and FDA-recognized voluntary consensus standards.

Documentation 52

Documentation Labelling 52

GMPSOP

SEPTEMBER 22, 2022

Additional documents included each month. Following is list of Major Defects typically found in incoming packaging lots: Delivery: – Seals not present – Missing polyethylene liner bag – Missing, illegible or incorrect pallet markings. Additional documents included each month.

Packaging 52

Packaging Documentation Labelling 52

FDA Law Blog: Biosimilars

MAY 19, 2023

Serial testing was defined as testing symptomatic individuals twice over three days with at least 48 hours between tests, which is in accordance with study findings from the National Institute of Health referenced here and current EUA labeling for serial testing. Customer Support Help line).

Labelling 40

Labelling Documentation 40

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

The new guidance is one of three policy documents dedicated to explaining FDA’s interpretation of this statutory authority and their approach to exercising scientific judgment in evaluating drug effectiveness. We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.

Drug Development 64

Drug Development Documentation Labelling Medical Records 64

European Pharmaceutical Review

JULY 20, 2023

SoHO entities must implement a traceability system to unmistakably link each SoHO donor to their SoHO donation and to all documents, samples, SoHO preparations and SoHO entities that are associated with that SoHO from the point of collection to human application and outcome monitoring.

Labelling 75

Labelling Documentation Hospitals 75

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.

Drug Development 103

Drug Development Documentation Biosimilars Compounding 103

RX Note

AUGUST 25, 2024

The same content of this book is presented in Lexicomp 's Natural Product database. FDA requires the labels of all herbal supplements to include the complete list of ingredients and manufacturers must follow good manufacturing practices (GMP) to ensure that supplements are processed consistently and meet quality standards.

Diabetes 52

Diabetes Community Pharmacies Dosage Documentation 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. Question 36: Dossier Submission.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 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. But for basic interventions like I just described, it makes the physician look good when they “fix up” orders based on your informal recommendations.

Hospitals 52

Hospitals Documentation Medical Records Inpatient 52