The FDA Law Blog

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

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FDA Documentation Vaccines 108

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. Type 1 affects 8% of everyone with diabetes.

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FDA Documentation Compounding Pharmaceutical Companies 98

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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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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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

STAT

DECEMBER 29, 2022

The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents.

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Insurance Documentation FDA 98

The FDA Law Blog

DECEMBER 4, 2023

Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” If the pharmacist can resolve it, they must make a record of the resolution. Complaint ¶ 55.

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Controlled Substances Documentation Dosage Prescription Filling 139

Pharmaceutical Technology

SEPTEMBER 15, 2022

The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database. AbbVie reported a 22.7%

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Vaccines Documentation Compounding FDA 108

European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs.

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Documentation FDA 105

The FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

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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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pharmaphorum

NOVEMBER 20, 2020

The announcement is no surprise as earlier this week, Pfizer’s CEO Albert Bourla said the company was preparing to file phase 3 data from the vaccine known as BNT162b2 with the FDA after gathering the required amount of safety data. billion doses by the end of 2021. Feature image courtesy of NIAID/Rocky Mountain Laboratories.

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Vaccines Documentation FDA 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

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

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

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

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

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma obtained exclusive rights from Henlius in 2021 for the development and commercialisation of HLX02 in Canada and the US.

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FDA Documentation 52

ISPE

MARCH 23, 2023

A True Copy is an exact copy of original documentation that preserves the same content, meaning and attributes of the original. It is an electronic copy maintained in an electronic document management system. This negates the requirement for storage of paper evidence and correct GMP document management of these hardcopy evidences.

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Documentation FDA 98

pharmaphorum

JANUARY 24, 2023

Biogen will have to make the case for its amyotrophic lateral sclerosis (ALS) therapy tofersen to an FDA advisory committee in March before it gets a decision on approval. The FDA started reviewing tofersen in July under its accelerated approval pathway, with a priority review that reflects the continued lack of effective therapies for ALS.

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FDA Documentation 45

Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.

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FDA Documentation Communication Hospitals 52

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The guidance also touched upon clinical trial design elements that must be explained, described, or rationalised to the FDA.

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FDA Documentation Communication 52

Pharma Marketing Network

APRIL 30, 2021

At this year’s Reuters Pharma Clinical 2021, I joined over 500 global leaders in clinical research as they discussed many of these issues under the theme, “rebuild clinical trials in the image of patient need.”. How do we increase the diversity of clinical trials?

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Pharmaceutical Companies Pharmaceutical Companies Documentation FDA 52

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.,

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Documentation FDA Communication Packaging 52

pharmaphorum

AUGUST 31, 2021

Still, in 2021, we have seen the industry evolve and develop strategies on how to establish a viable ECA. The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. To be clear, there will always be challenges in drug development, and stakeholders are no stranger to this.

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FDA Insurance Coverage Documentation Pharmaceutical Companies 89

pharmaphorum

DECEMBER 17, 2020

The company’s lead candidate Tenapanor is a targeted, small molecule therapy currently under FDA review. The company’s lead candidate, Tenapanor, is a targeted, small molecule therapy under FDA review for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

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FDA Documentation Patient Care 104

The FDA Law Blog

OCTOBER 5, 2022

eSTAR employs targeted questions to collect specific data and information and includes applicable links to regulations, relevant guidance documents, and other resources. This has the potential to make the FDA’s review efficient as relevant information is collected upfront. printing to PDF) that states comments will not be sent to FDA.

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Documentation FDA 45

Pharmaceutical Technology

MARCH 30, 2023

In August 2021, MSD was able to convert Keytruda’s accelerated approval for its use in in patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-based chemotherapy, into a full approval. GlobalData is the parent company of Pharmaceutical Technology.

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Chemotherapy Packaging FDA Documentation 52

The FDA Law Blog

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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FDA Documentation 52

PharmaShots

JUNE 14, 2023

The diagnostic and testing companies have been serving as a pivotal foundation stone of the healthcare sector With a global market value of $165.58B in 2021, the diagnostic and testing market size is anticipated to touch the threshold of $348.75 Varex’s 2022 diagnostic segment revenue increased by 4.69% as compared to 2021.

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FDA Hospitals Documentation Patient Care 56

The FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR.

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Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Gilenya is an oral medication for multiple sclerosis. 10,633,344.

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Documentation FDA Hospitals Dosage 97

The FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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FDA Documentation 59

ISPE

OCTOBER 28, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. The outcomes of these inspections were shared extensively with MRA partners such as EMA and US FDA. Canada DHPID ).

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FDA Vaccines Documentation Dosage 97

pharmaphorum

APRIL 16, 2021

IQVIA’s Sarah Rickwood reviews the launch of innovative medicines in 2020 and outlines three key pillars of activity for companies to focus on and address in 2021. Even with the vaccine roll-out, further waves of COVID infection and lockdowns mean these vital drivers of launch performance remain impacted in 2021, and even beyond.

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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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The FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Existing published VCS may be identified internally by FDA or externally by stakeholders.

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