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

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 90

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

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

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. As of 2019, about 1.9 The treatment comes as a 14-day course of infusions that each last 30 to 60 minutes.

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FDA Documentation Compounding Pharmaceutical Companies 98

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 People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

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

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

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

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

pharmaphorum

AUGUST 16, 2021

Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials. In 2019, Formedix collaborated with a UK-based consortium interested in observing early safety data. This gives great risk for human error and misinterpretation.

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Documentation Vaccines Packaging Pharmaceutical Companies 98

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

APRIL 16, 2021

Approval by regulators such as the FDA or EMA, as reported by the regulators themselves. Both the FDA and the EMA rose to the pandemic regulatory challenge very well – addressing the specific COVID treatment and vaccination needs, as well as keeping standard medicines approvals going.

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Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 95

ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. The US FDA monitors quality, and Kopcha traced changes in regulation of quality over the years. FDA Activities in Support of Quality. Tue, 11/01/2022 - 06:49.

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FDA Insurance Chemotherapy Documentation 98

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

Documentation 52

Documentation FDA Communication Packaging 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.

Documentation 98

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.

Labelling 52

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

pharmaphorum

MARCH 18, 2021

First approved for mantle cell lymphoma (MCL) in 2017, Calquence sales have rocketed since its approval for CLL towards the end of 2019, rising to $522 million in 2020 from $164 million in the prior year. Daiichi Sankyo gets okay for cholesterol drugs. The post NICE backs AZ’s Calquence for new use in leukaemia appeared first on.

Hospitals 52

Hospitals Chemotherapy Documentation FDA 52

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.

Documentation 52

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.

Documentation 52

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

OCTOBER 26, 2022

For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, 11.

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Vaccines Compounding Documentation FDA 97

ISPE

SEPTEMBER 11, 2023

2 October 2019. Meet Eli Lilly and Company - 2019 Facility of the Year Process Innovation Category Winner.” 11 September 2019. 6 November 2019. 12 July 2019. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” BioPharm International. iSpeak blog. link] 33 Adiga, R., iSpeak blog.

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Health and Personal Care Stores Vaccines Packaging Documentation 52