BioPharm

SEPTEMBER 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

Labelling 52

Labelling Documentation FDA 52

pharmaphorum

JUNE 16, 2021

With the first patient set to receive Biogen’s new Alzheimer’s drug Aduhelm in Rhode Island today, US consumer advocacy organisation Public Citizen is deeply unhappy about the FDA’s approval of the drug – and it wants the scalps of those responsible.

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FDA Documentation Labelling 92

The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. Notably, Part 820 will look different. The new § 820.10

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FDA Labelling Packaging Documentation 59

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Loose Ends IDEs.

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FDA Documentation Labelling Communication 105

The FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 820), labeling (21 C.F.R. Post-market requirements cover activities such as registration and listing (21 C.F.R.

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Documentation FDA Labelling 98

The FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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FDA Documentation Packaging Communication 75

The FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ).

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FDA Documentation Labelling Communication 59

Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). Outlook stated that ONS-5010 will get 12 years of regulatory exclusivity in the US if it is approved by the FDA.

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FDA Compounding Pharmacies Labelling Compounding 59

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

pharmaphorum

DECEMBER 30, 2022

The FDA’s interactions with Biogen in the build-up to last year’s controversial approval of Alzheimer’s disease therapy Aduhelm have been described as “inappropriate” and “atypical” in a congressional report on the review.

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FDA Documentation Labelling 59

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

The Checkup by Singlecare

JUNE 28, 2024

It’s in a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists, approved by the Food and Drug Administration (FDA) to manage blood sugar levels in adults with Type 2 diabetes when combined with diet and exercise. In fact, the drug often sees shortages due to high demand for off-label prescriptions for weight loss.

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Insurance Insurance Coverage Labelling Medical Records 96

The FDA Law Blog

MAY 8, 2023

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). a) , and related guidance documents (e.g., 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

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Without commenting on the merits of the decision, it is an interesting window into how FDA may use these new procedures in practice. Tobolowsky & Michelle L.

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FDA Documentation Labelling 59

The FDA Law Blog

JULY 7, 2024

Unfortunately, the guidance for small entities recently published by FDA is little more than a summary digest of the multi-hundred-page final rule. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.

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Labelling FDA Communication Documentation 64

The Checkup by Singlecare

DECEMBER 28, 2023

Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent. Weight loss is an off-label , non-FDA-approved use for Ozempic. The FDA has urged consumers to use caution when taking medication from these compound pharmacies.

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Insurance Insurance Coverage FDA Documentation 104

The FDA Law Blog

FEBRUARY 22, 2023

Shapiro — More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec. FDA did not require HF data as a basis for clearance of the predicate.

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FDA Documentation Labelling Hospitals 64

The FDA Law Blog

JANUARY 1, 2024

Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Dextrum Laboratories Inc.

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FDA Documentation Labelling 59

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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FDA Documentation Labelling Communication 105

The FDA Law Blog

OCTOBER 18, 2022

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. FDA published draft guidances for these topics in December 2021 ( here and here ).

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Documentation FDA Labelling 52

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 19, 2023

Livornese — Last week FDA checked off another item on its to-do list for implementing the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) OTC monograph reform provisions. As provided in the OMUFA Performance Goals letter , FDA issued draft guidance on the content and format of submissions. By Deborah L.

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Documentation FDA Labelling 59

The Checkup by Singlecare

DECEMBER 1, 2023

That is 170% of the daily value (DV) recommended by the US Food and Drug Administration (FDA). 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. mcg or 100–144 IU per cup.

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Labelling Mayo Clinic FDA Immunization 93

pharmaphorum

DECEMBER 14, 2022

An FDA advisory committee has voted against approval of Cytokinetics’ cardiac myosin inhibitor omecamtiv mecarbil for heart failure, saying the data for the drug was not strong enough. The agency’s reviewer took issue with the scientific rigour of GALACTIC-HF in a document published in advance of the meeting.

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FDA Documentation Labelling 52

pharmaphorum

OCTOBER 30, 2022

Shares in US biotech Y-mAbs Therapeutics have lost almost a third of their value after FDA advisors unanimously rejected its brain cancer therapy 131I-omburtamab in 16 to 0 vote. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

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FDA Documentation Labelling Immunization 52

The FDA Law Blog

OCTOBER 5, 2022

By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

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FDA Labelling Packaging Documentation 52

The FDA Law Blog

OCTOBER 26, 2022

Walsh — The question of whether FDA has authority to take pictures during an inspection of a facility has bounced around the food and drug bar for many years. FDA’s view is stated in the agency’s Investigation Operations Manual, and it is one with which a number of practitioners disagree. By Ricardo Carvajal & Anne K.

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FDA Labelling Documentation 59

The Checkup by Singlecare

AUGUST 3, 2024

Latuda (lurasidone) is a brand-name prescription drug that’s approved by the Food and Drug Administration (FDA) to treat schizophrenia as well as bipolar depression associated with bipolar I disorder. It’s also sometimes prescribed off-label to treat major depressive disorder and other mental health conditions.

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Insurance Coverage Insurance Dosage Labelling 90

The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. FDA interprets the term “pattern” to mean “multiple, sequential, or repeated measurements of a signal or from a signal acquisition system.”

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FDA Labelling Documentation Communication 52

The Checkup by Singlecare

FEBRUARY 23, 2024

Food and Drug Administration (FDA), there is no official guidance on how much to take. In the documented reports, the signs of acute liver injury included jaundice, nausea, lethargy, pruritus, abdominal discomfort, and hyperbilirubinemia. Since this is an herbal remedy, not regulated by the U.S.

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Immunization FDA Documentation Labelling 105

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

The FDA Law Blog

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.

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Labelling Packaging FDA Documentation 45

The Checkup by Singlecare

JULY 9, 2024

It’s also approved by the Food and Drug Administration (FDA) to treat schizophrenia. Adults, adolescents, and children 10 years and older Adults, adolescents, and children 7 years and older Latuda vs. lithium: Conditions treated Through rigorous clinical trials and documentation, the FDA approves medications for very specific uses.

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Insurance Dosage Labelling FDA 80

The FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. And the Guidance may be used as leverage to secure action from FDA on a meeting request.

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FDA Packaging Documentation Labelling 45

OctariusRx

MAY 13, 2024

Food and Drug Administration (FDA) receives more than 100,000 reports associated with a suspected medication error. Since medications are usually dosed milligrams per kilogram, learn to consistently convert and document the patient’s weight in kilograms. Do you know the components of a completely and properly labeled syringe?

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Long-Term Care Facilities Labelling Medication Labelling Documentation 69

The FDA Law Blog

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. Several sections of the eSTAR templates have questions that walk through related guidance documents. By Adrienne R. Know Your Guidances.

Documentation 52

Documentation Labelling Communication FDA 52

The Checkup by Singlecare

JULY 20, 2024

Food and Drug Administration ( FDA ) as a weight loss medication. As of now, phentermine is not FDA-approved for ADHD, and the evidence of its effectiveness is scarce. However, healthcare professionals sometimes prescribe phentermine for off-label uses, such as for the treatment of ADHD. Can phentermine be used to treat ADHD?

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Adverse Reactions FDA Controlled Substances Documentation 86