The FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). Youth behavioral data was not specifically required but FDA encouraged such information.

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FDA Documentation 115

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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FDA Documentation Communication 105

pharmaphorum

APRIL 27, 2021

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

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FDA Chemotherapy Documentation 89

European Pharmaceutical Review

DECEMBER 21, 2022

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. 1 The European Directorate for the Quality of Medicines & Healthcare (EDQM) also accepted LBP as a new category of medicinal products for the European market in 2019.

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Documentation FDA 111

The FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

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FDA Medical Records Documentation 111

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

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. stated, “ We appreciate the IOM’s report on the 510(k) program.

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Documentation FDA 64

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

European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

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Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 98

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 Communication Labelling 105

The FDA Law Blog

OCTOBER 2, 2023

Sasinowski — This time last year, we wrote about a long-overlooked FDA statutory authority and wondered if this provision, known colloquially as the “single study plus confirmatory evidence” pathway, was having a moment (previous post here ). Valentine & Frank J.

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FDA Documentation Labelling Medical Records 64

pharmaphorum

NOVEMBER 17, 2022

While the FDA seems to remain sceptical about the clinical benefits of Ardelyx’ chronic kidney disease (CKD) therapy Xphozah – having rejected its marketing application in 2021 – its advisors are more confident abut the drug. The post FDA panel backs Ardelyx CKD drug, despite agency concerns appeared first on.

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FDA Documentation 52

The FDA Law Blog

OCTOBER 2, 2024

As a reminder, a PCCP is a document submitted in a marketing application that describes future modifications to a device that would typically require submission of a subsequent application and a description of how the sponsor will verify and validate the modified device. Draft Guidance at 4. Change Guidance at 8.

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FDA Documentation Hospitals 59

Impact Pharmaceutical Services

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Image courtesy of qimono at pixabay.com.

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FDA Documentation Communication 52

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. If additional documentation is needed, it can be submitted at this stage.”

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Insurance Insurance Coverage Labelling Medical Records 96

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 gives no rationale for interpreting the apparently broad statutory term “medical information” in such a restrictive manner.

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FDA Labelling Documentation Communication 52

The FDA Law Blog

OCTOBER 11, 2022

Valentine — As we begin the final quarter of 2022 and the leaves here on the east coast begin to turn and fall, it seems the clock may be running out on FDA and the Center for Drug Evaluation and Research (CDER) to meet its goal of publishing a draft guidance on confirmatory evidence this year. Sasinowski & James E.

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FDA Documentation Labelling 61

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 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. In 2019, the FDA approved a generic version of Latuda (lurasidone) , which just became available in 2023.

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Insurance Coverage Insurance Dosage Labelling 92

Pharmaceutical Technology

SEPTEMBER 15, 2022

According to GlobalData’s report, Coronavirus Disease 2019 (Covid-19) Analyst Consensus Sales Analysis and Forecast, H1 2022 , Comirnaty is the leading prophylactic Covid-19 vaccine and recorded sales of $41.3bn in 2021. Bristol Myers Squibb (BMS) documented a 9.1% Amgen reported only a marginal 2.2%

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Vaccines Documentation Compounding FDA 108

European Pharmaceutical Review

SEPTEMBER 22, 2022

The application of Bayesian methodology has been recognised by the US Food and Drug Administration (FDA) as useful in early phase clinical trials involving paediatric populations. FDA presentation. FDA Rare Diseases: Natural History Studies for Drug Development Guidance for Industry. Regulatory and payer guidance. Patel et al.

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Pharmaceutical Companies Pharmaceutical Companies FDA Documentation 122

Pharmaceutical Technology

MARCH 30, 2023

Earlier in March, the FDA shared a draft guidance on how to run clinical trials for the accelerated approval of cancer drugs. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials.

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Chemotherapy Packaging FDA Documentation 52

pharmaphorum

JULY 27, 2022

The paper, by a team from Imperial College London, concluded that the FDA gave the go ahead to 95% of the 89 products approved between 2010 and 2019 before EMA, with the Europeans trailing the Americans by a median of 241 days.

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Documentation FDA 98

The Checkup by Singlecare

DECEMBER 1, 2023

Food and Drug Administration (FDA) certifies the Red Dye 40 as safe for human consumption. Apart from Red Dye 40, there are eight other certified color additives approved for use in food by the FDA: Blue No. The FDA has denied any link between the two for years. The controversy surrounding Red Dye 40 The U.S. 1, Blue No.

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Labelling FDA Documentation 52

pharmaphorum

NOVEMBER 30, 2020

Biogen has invested heavily in its Alzheimer’s candidate aducanumab, but an FDA advisory committee was unimpressed with the company’s rehashed data for the anti-amyloid drug and voted that it didn’t support efficacy. million, around the same level as the same period of 2019.

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FDA Documentation 45

Pharmaceutical Technology

JANUARY 27, 2023

In 2019, Cablivi became the first FDA-approved , nanobody-based medicine for acquired thrombotic thrombocytopenic purpura (aTTP), an ultra-orphan condition that causes blood clots in small blood vessels around the body. However, Sanofi’s agreement is particularly unique in the way that it measures outcomes.

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Documentation Immunization Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published November 2019. As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed.

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Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published November 2019. As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MAY 11, 2023

Also, determining whether an intrusion occurred and documenting that intrusion adds to the challenges of performing aseptic technique properly (and perhaps adds to the subjectivity of the current control strategies). link] 7 ISO Standard 14971:2019. December 2019. ICH Harmonised Tripartite Guideline Q9: Quality Risk Management.”

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Documentation Labelling FDA 52

Pharmaceutical Technology

APRIL 13, 2023

However, numbers are still much higher than 2019, indicating the use of telemedicine is set to remain post-Covid. In the US, the FDA (Food and Drug Administration) granted accelerated approvals of medical devices with AI in 2022 [8] , and growing use is expected throughout 2023. For example, the patient completing an e-diary.

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Documentation Communication FDA 52

ISPE

JULY 10, 2023

The Roche Global Engineering team developed an Air Change Rate Reductions Best Practices Guide in 2019 1 to guide these pharmaceutical manufacturing site surveys and to challenge and optimize existing installations that use high ventilation rates with the intent of maintaining particulate levels required for manufacturing environmental quality.

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Documentation FDA 52

The Spirit Pharmacist

FEBRUARY 21, 2023

The only FDA approved treatment for post-partum depression is a progesterone analogue that must be delivered over a 60-hour IV infusion and appears mildly efficacious. There have been a couple of small case series document LSD use in pregnancy and normal birth outcomes, although these are not high quality or conclusive by any means [23].

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Documentation Compounding Immunization FDA 98

pharmaphorum

AUGUST 19, 2022

Since DiMe’s launch in October 2019, there has been a 929% increase in the number of digital endpoints being used by the life sciences industry for the safety and efficacy of new drug development. Yet we remain unprepared to access reliable and trustworthy sensor data at scale. Sensor Data Standards Toolkit.

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Documentation Patient Care Hospitals FDA 52

ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. 3 , 4 RAMI integrates all assets, including physical items, software, administrative shell, documents, and personnel. Pharmaceutical Engineering (May/June 2019). Methodology to Define a Pharma 4.0™

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Packaging Documentation Communication Data Entry 52

ISPE

SEPTEMBER 8, 2023

USA The FDA established the Emerging Technology Program (ETP) in 2014 and has actively promoted the program 8. Project Orbis was started in May 2019 by the FDA’s Oncology Center of Excellence (OCE) to enable faster global access to cancer treatments. Published November 2019. 22 June 2023. EMA/321483/2020. 3 July 2020.

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FDA Documentation Dosage Communication 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 9 In 2015, the FDA published a guidance manual 10 that provided questions for inspections, including: Is the air flow in critical areas unidirectional when delivered to the point of use? ASHRAE Journal (2019): 38–54.

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Documentation FDA Packaging Communication 52

ISPE

MAY 10, 2023

1 May 2023 Funded by the European Commission from 2019, the Smart Pharmaceutical Manufacturing Project (SPuMoNI) 1 harnesses the potential of state-of-the-art technologies for the pharmaceutical industry. Juan Miguel García-Gómez, Ph.D. Chis, Ph.D. Horacio Gonzalez-Velez, Ph.D. This article discusses the main SPuMoNI accomplishments.

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Chemotherapy Documentation Dosage Communication 52