FDA Law Blog: Drug Discovery

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. FDA Law Blog readers can use discount code S10-866-866L24.S S for reduced registration fees.

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Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. However, patients also play a vital role in engaging directly with the FDA. It also means sponsors are less likely to waste time and resources developing programs that don’t work for patients.”

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The Premier Consulting Blog

NOVEMBER 12, 2023

In 2019, the FDA published a discussion paper on a proposed regulatory framework for modification to AI/ML-based software as a medical device (SaMD), which received a significant amount of feedback from stakeholders. FDA Discussions As a result of the feedback received in 2019, the FDA outlined the five-pillar approach to regulating AI/ML.

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The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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Pharmaceutical Development Group

FEBRUARY 1, 2022

Effective cost and timeline reductions of NME & NCE electronic submissions are most likely achieved via proactive, early utilization of Drug Development Services, 505(b) NDA , IND Consulting , NDA Consulting , BLA Consulting , and effective FDA Pre-Submission collectively resulting in FDA and Regulatory Body Clearance/Approval.

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Pharmaceutical Development Group

JANUARY 7, 2022

Effective and consistent use and application of Data Standards can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, 505(b) NDA, IND Consulting , NDA Consulting, BLA Consulting , and effective FDA Pre-Submission collectively resulting in FDA Approval.

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Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Operation Warp Speed for Rare Diseases looks to accelerate both drug development and approval.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). The meeting will take place virtually on April 13, 2023, from 11:00 AM to 3:00 PM ET.

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Agency IQ

JULY 12, 2024

FDA gives companies leeway to go after misinformation, but not free reign In a new revised draft guidance document, the FDA says it will allow life sciences companies to address misinformation about their products that is posted online. In regulation, intended use is defined at 21 CFR 201.128 for drugs and 21 CFR 801.4

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The Premier Consulting Blog

JUNE 26, 2023

1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Rare cancers account for 25-30 percent of all new cancer diagnoses and 25 percent of cancer deaths.

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The Pharma Data

NOVEMBER 24, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is what OIRA is currently reviewing.

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Conversations in Drug Development Trends

OCTOBER 29, 2024

Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.

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Agency IQ

JUNE 26, 2023

FDA quietly kicks off process that could inform future rare disease regulatory reforms Reforms buried within the FY2023 omnibus spending bill require the development of a new report looking at the regulatory processes of the U.S. legislators have asked the FDA to study the way that rare disease drugs are regulated in the U.S.

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Agency IQ

JANUARY 19, 2024

The work could represent early steps toward modernizing one part of FDA’s regulation of this complicated product class. BY AMANDA CONTI | JAN 16, 2024 7:43 PM CST Regulatory background: complex generics Unlike new drug products, generic drugs do not require extensive clinical evidence to demonstrate safety or efficacy.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. But could it be a busy month for rulemaking?

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Agency IQ

AUGUST 23, 2024

The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. FDA has not made a formal public announcement, but Lias was referring to ROSS D.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. FDA is also due to revise 24 other guidance documents at that time.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

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H1 Blog

MAY 25, 2023

Bridging the Gap Between Pharmaceutical Development and Advancement of Therapeutics In the race to bring new treatments and cures to market, clinical trial operations and feasibility teams often face a formidable challenge: ensuring that patient populations are accurately represented in their drug development studies.

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Agency IQ

DECEMBER 1, 2023

FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version Last week, FDA published the third update to its guidance on the development of products to prevent or treat Covid-19. Read Agency IQ’s complete breakdown of the FDA’s PHE guidance documents here.]

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The Pharma Data

MAY 17, 2021

Acting FDA Commissioner. During this global pandemic, the FDA worked to protect the American public by using every tool at its disposal to quickly review and act on new therapies for COVID-19. Conducting clinical trials to see if a drug is safe and effective can be a very time-consuming process. .

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. In 2006, FDA stated that DMCs were not recommended “for most clinical studies,” particularly those in early product development, short-term studies, or studies addressing less severe outcomes.

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Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

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Agency IQ

FEBRUARY 12, 2024

In terms of organization, the playbook starts with an introduction to the BGTC, provides an overview of the playbook’s development, and offers advice on it can be used. Although the document briefly touches on the technical aspects of drug development, most of the content in the playbook focuses on early touchpoints between sponsors and FDA.

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Agency IQ

NOVEMBER 3, 2023

Top questions on FDA’s proposed LDT rule: Carve outs, capacity and quality systems A month after the FDA published its proposed rule to enforce regulatory requirements on laboratory developed tests (LDTs), AgencyIQ has some outstanding questions. IVDs are regulated as medical devices in the U.S.,

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The Pharma Data

MARCH 15, 2022

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, Ph.D.,

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KIF1A

JANUARY 13, 2024

This process is regulated so we end up with the right number of neurons, which we can imagine with some simplified math: If you start with one progenitor and need eight neurons, it isn’t efficient for that progenitor to make a single neuron eight times.

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Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. Author Information William E. Spanogle, Ph.D. Spanogle, Ph.D.

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Agency IQ

FEBRUARY 12, 2024

FDA and EMA re-launch parallel advice pilot for complex generics The path to market for complex generics and hybrid products is complicated, and regulatory harmonization efforts in this space are lacking. FDA and EMA launched the Parallel Scientific Advice (PSA) Pilot Program for Complex Generic/Hybrid Products in September 2021.

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Agency IQ

JULY 28, 2023

In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward This week, the FDA issued four new contract notices that highlight agency priorities in meeting user fee commitments, ongoing work in oncology dose optimization, and continued commitment to addressing the opioid crisis.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

The phrase in subsection (ii) “authorized for investigation as a new drug” is generally accepted to mean that an IND is in effect. Under FDA’s interpretation, it is impossible to determine whether there is a non-public IND prior to starting work on developing an ingredient as a dietary supplement. What led to NPA’s lawsuit?

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FDA Law Blog: Biosimilars

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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Agency IQ

SEPTEMBER 1, 2023

FDA finalizes guidance on oversight of RWE studies, making several significant changes The FDA today finalized a much-anticipated guidance document on how sponsors of drugs and biologics can oversee and make use of their non-interventional studies involving real-world data and evidence.

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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. To assess signals of serious risk related to the use of the drug.”

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