The FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

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Labelling FDA Documentation 52

The Checkup by Singlecare

DECEMBER 6, 2024

Because clonidine works differently than other blood pressure medications, it also has several off-label uses including anxiety, insomnia, attention deficit hyperactivity disorder (ADHD), and alcohol withdrawal. Alcohols negative effects on the liver are well-documented. Does clonidine help with alcohol withdrawal?

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Labelling Documentation FDA 98

pharmaphorum

APRIL 28, 2021

exploring ‘validation ready’ global labeling systems . ? . A group of industry experts is set to explore how medical device, clinical trial and pharmaceutical companies can proactively manage labeling risk. The post Experts to come together for compliance event ‘validation ready’ global labeling systems appeared first on.

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Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

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European Pharmaceutical Review

AUGUST 23, 2022

Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively. Overall, validation, documentation and quality control were the major cGMP violations.

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FDA Documentation Packaging Labelling 105

pharmaphorum

SEPTEMBER 2, 2020

The guidance published on the Medicines and Healthcare products Regulatory Agency (MHRA) website is broadly similar to arrangements laid out in a Brexit “no deal” document published last year.

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Documentation Labelling 124

European Pharmaceutical Review

JULY 4, 2023

The document contains requirements and guidance for testing for bacterial endotoxins. This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both. This document relating to microbiological methods is based on ANSI/AAMI ST72. Why is bacterial endotoxin testing important?

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Documentation Labelling 111

The Checkup by Singlecare

JUNE 5, 2025

Blue Cross Blue Shield doesn’t typically cover Mounjaro for weight loss because it’s considered an off-label use of the drug. You can also log in to your health insurance portal to access policy documents. Check the document glossary to understand the meaning of each tier. Look for Mounjaro on the list of drugs.

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Insurance Compounding Documentation FDA 52

Pharmaceutical Technology

JUNE 19, 2023

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.

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Labelling Packaging Documentation Dosage 52

IDStewardship

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.

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Medication Guidelines Documentation Labelling Hospitals 299

The Checkup by Singlecare

JULY 2, 2025

A portion of Aetna’s plans label Vyvanse as a “non-preferred” drug, meaning it’s typically not covered or minimally covered, preferring generic lisdexamfetamine dimesylate instead. In these cases, they may require the healthcare provider to submit additional documentation of treatments, symptoms, or side effects from other drugs tried.

Insurance 52

Insurance Insurance Coverage Documentation Controlled Substances 52

pharmaphorum

MAY 25, 2022

Here, we take a look at the top five takeaways from the document: 1. Companies should still clearly document their reasons for supporting events, including virtual and hybrid international congresses, said the document. Identifying the appropriate code and label. The codes still apply. End of the host country.

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Documentation Communication Labelling 105

pharmaphorum

JUNE 8, 2022

The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them.

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Documentation Labelling FDA 131

pharmaphorum

OCTOBER 6, 2020

Apply Data: Regulatory employees should be using stored data to intelligently create submission documents. By limiting documents full of free text fields and subjectivity companies can adopt a more digitised approach, where document templates can be compiled automatically from available data. Label Authoring and Tracking.

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Documentation Communication Labelling Data Entry 114

The FDA Law Blog

FEBRUARY 7, 2023

Part 820), labeling (21 C.F.R. In practice, a standard operating procedure for design controls is developed to describe how medical device design will be performed and documented. First, a design history file includes many documents that must be submitted as part of a 510(k), De Novo, or premarket approval (PMA) application.

Documentation 98

Documentation FDA Labelling 98

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

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Adverse Reactions Documentation Medical Schools Packaging 96

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B. Loose Ends IDEs.

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FDA Documentation Labelling Communication 105

Viseven

JUNE 18, 2025

Compliance & documentation : Ensuring scientific interactions, data sharing, and materials comply with regulatory and ethical standards, monitoring for compliance risks. Label expansion Label expansion is an important but costly process of gaining regulatory approval for new indications, patient populations, or dosing regimens.

Labelling 52

Labelling Communication Documentation Pharmaceutical Companies 52

European Pharmaceutical Review

JUNE 12, 2025

Inconsistencies : data should be formatted and labelled in a well-defined way, as ambiguity would trick both humans and models. Data traceability and immutability : meticulously documenting metadata pertaining to data sources, quality and context, to provide AI applications with the necessary contextual information during data processing.

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FDA Documentation Labelling 52

The Checkup by Singlecare

JUNE 28, 2024

In fact, the drug often sees shortages due to high demand for off-label prescriptions for weight loss. Although some healthcare providers prescribe Ozempic off-label for weight loss, insurance often won’t cover Ozempic for these uses unless it’s medically justified and no alternative treatments exist.

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Insurance Insurance Coverage Labelling Medical Records 96

The Checkup by Singlecare

JULY 2, 2025

This means that even if your plan provides coverage for this medicine, your healthcare provider will likely need to submit a prior authorization (PA) —documentation explaining why you need this medication. For example, you may be able to get coverage for liraglutide (generic Victoza ) off-label for weight loss.

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Insurance Insurance Coverage Documentation Prescription Filling 52

The Checkup by Singlecare

JUNE 5, 2025

Because of those effects, Mounjaro is sometimes prescribed off-label for weight loss. This means the Aetna plan will only cover Mounjaro if the patient’s medical provider provides documented proof that the person meets certain requirements, such as a diabetes diagnosis or concerning blood glucose levels.

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Insurance Coverage Insurance Compounding Mail-Order Pharmacies 52

The FDA Law Blog

FEBRUARY 13, 2025

The manufacturer should, in addition to stating whether the modification will be implemented manually or automatically, include details such as: End user actions needed, if any to implement the change, Timing of implementation, Extent of implementation in the install base, and Include references to expected labeling changes.

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FDA Documentation Labelling Method Validation 71

Pharmaceutical Technology

OCTOBER 31, 2022

Outlook Therapeutics president and CEO Russell Trenary said: “This BLA acceptance and PDUFA date are significant milestones in our mission to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD. “If

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FDA Compounding Pharmacies Labelling Compounding 59

The Checkup by Singlecare

DECEMBER 1, 2023

Department of Agriculture (USDA) requires it to be labeled “farmed” or” wild-caught.” Check the nutrition facts label to find the amount of vitamin D and other nutrients contained in individual products. The nutritional fact label will identify the recommended daily value of vitamin D suggested for the average adult.

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Labelling Mayo Clinic FDA Immunization 93

The FDA Law Blog

OCTOBER 18, 2022

Amongst CDRH’s highest prioritized device guidance documents are final versions of the transition plans for medical devices that fall within enforcement policies or that were issued emergency use authorizations (EUAs) during Covid-19 public health emergency (PHE). They are also open to information to include in these guidance documents.

Documentation 52

Documentation FDA Labelling 52

Pharmaceutical Technology

SEPTEMBER 5, 2022

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Quality in terms of number of defective items, packaging and labelling, quality management system certification, research, development, and innovation.

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Documentation Packaging Labelling Pharmaceutical Companies 52

The FDA Law Blog

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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FDA Labelling Packaging Documentation 59

The FDA Law Blog

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.

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FDA Documentation Labelling Communication 59

The FDA Law Blog

FEBRUARY 28, 2023

The general structure of our submissions, and of many others that we have seen, is to have a document for each of the twenty sections and then to refer to other files, such as labeling and test reports, as attachments. Several sections of the eSTAR templates have questions that walk through related guidance documents.

Documentation 52

Documentation Labelling Communication FDA 52

pharmaphorum

JUNE 16, 2021

Aside from the lack of evidence that Aduhelm (aducanumab) provides any meaningful clinical benefit is “the fact that the drug has a well-documented risk of potentially serious brain injury,” wrote Carome in the letter.

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FDA Documentation Labelling 92

The FDA Law Blog

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)

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FDA Documentation Labelling 98

The FDA Law Blog

APRIL 19, 2023

The new draft guidance continues to borrow heavily from the NDA process and FDA notes that it used the same source material on which other drug application recommendations are based including the Common Technical Document (CTD). x 11-inch paper, and with hyperlinks to references and numbered pages.

Documentation 59

Documentation FDA Labelling 59

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. Biogen’s hopes were for sales of around $18 billion per year from Aduhelm, says the document, without consideration of the impact that could have on the US healthcare system.

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FDA Documentation Labelling 59

Pharma Marketing Network

MARCH 18, 2025

Avoiding misleading claims or unapproved off-label promotions. Keep Detailed Records of PPC Campaigns Document ad approvals, compliance reviews, and campaign changes to maintain transparency in case of audits. Best practices include: Clearly stating the drug name, indications, and fair balance information.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 52

The Checkup by Singlecare

JUNE 6, 2025

Before covering Ozempic for an off-label use like fatty liver disease, your insurance company may require prior authorization. This involves submitting necessary documentation, with the help of your healthcare provider, to justify the need for the medication.

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Insurance FDA Health Insurance Companies Labelling 52

The Checkup by Singlecare

FEBRUARY 7, 2023

Eligible patients will be required to provide documentation of financial and insurance information to show they have no means of obtaining the medication without assistance. not being used off-label). “PAPs all work in the same way, although there are differences depending on the specific program,” he says.

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