FDA Law Blog: Drug Discovery

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. The draft guidance therefore continues to “recommend” sponsors go beyond what is required in its regulations in its communications to FDA based on DMC recommendations, highlighting the tension between what FDA needs and what it wants.

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Clinical Trials Trials FDA Regulations 105

Conversations in Drug Development Trends

MAY 1, 2024

Early and Ongoing Engagement Will Save Effort During Your Oncology Clinical Trial Early and ongoing engagement with regulatory agencies is invaluable; initiating dialogue early in the development process facilitates a clearer understanding of regulatory requirements and expectations and builds a relationship with regulators.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients. What led to NPA’s lawsuit?

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Drug Target Review

OCTOBER 31, 2023

Regulatory affairs workers get to tell a story about a drug to the regulators and – keeping the end in mind, which is the drug label or prescribing information – is a good way to communicate with regulators. Every drug has a story: an end game. By definition, this is the cutting edge, and we are in it.

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Perficient: Drug Development

FEBRUARY 22, 2024

The Folly of Following Trends Trends are, by definition, people following a current style or popular approach. At that time, their industry was driven by government regulations and tariffs. Not once have I had a group who wasn’t able to produce an intriguing idea within five to ten minutes based on a random word. Great ideas abound!

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Perficient: Drug Development

JANUARY 24, 2024

Before I begin, I just want to caveat everything with the fact that HIPAA is a complex regulation open to interpretation, and in the end your legal and compliance teams need to be comfortable with how you handle data and the risk associated with those methods. The other part of the definition is what constitutes “health information.”

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Licensing Licensing Production Regulations 96

Perficient: Drug Development

AUGUST 21, 2024

Understanding Adaptive and Assistive Technologies Adaptive Technologies: Definition: Adaptive technologies are specialized tools and modifications designed to assist individuals with disabilities in performing tasks that might otherwise be challenging or impossible. These technologies often support independence and improve quality of life.

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The Premier Consulting Blog

OCTOBER 11, 2022

Key Takeaway RWD and RWE play an important role in rare diseases, where capturing relevant data to support drug development is challenging. To learn more about using RWD and RWE in rare disease programs, read our guide on Using Real-World Data and Real-World Evidence to Support Rare Disease Programs.

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Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

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FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. The guidance’s second warning reminds drug developers that FDA regulations (i.e.,

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Agency IQ

JULY 22, 2024

While the agency has been working to implement its rule, which has broad-reaching impacts for diagnostics and drug developers, other moves by the Supreme Court and legislators could impact the agency’s next steps. AgencyIQ provides a status update for regulated industry. diagnostic products are regulated as medical devices.

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Agency IQ

JUNE 26, 2023

Today, the FDA unveiled a contract notice that explains the process for how it will develop that report, obtain public input, and deliver the report’s final recommendations. a disease or condition is defined as rare by the Orphan Drug Act (ODA) if it affects fewer than 200,000 people. regulators. In the U.S., Recently, U.S.

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Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S.,

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Agency IQ

NOVEMBER 3, 2023

In particular – potential issues with applying the policy to practice, the role of different stakeholders and the new proposed definitions. IVDs are regulated as medical devices in the U.S., However, this definition presents many questions. but since the 1970s, the FDA has expressed “enforcement discretion” (i.e.,

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The Premier Consulting Blog

MARCH 13, 2023

In addition to describing the intended purpose of the procedure, the ATP outlines anticipated performance criteria and Critical Quality Attributes (CQAs), which facilitate technology selection, procedure design and development, performance monitoring, and continual improvement.

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Perficient: Drug Development

MARCH 22, 2024

Even the definition of “good” is harder to define with unstructured data than structured data. Conclusion Enterprise data, particular in regulated industries, rely on robust, effective and ubiquitous quality pipelines. Working with unstructured data, particularly at scale, can be difficult. An elusive goal, at best.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

The standards would, as stated previously, be voluntary, unless mandated by statute or regulation, and they cannot conflict with existing law or regulation. Consensus does not require unanimity, but a general agreement. Existing published VCS may be identified internally by FDA or externally by stakeholders.

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity.

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Agency IQ

DECEMBER 15, 2023

Key stakeholders weigh in on FDA’s Laboratory Developed Test Rule. The 60-day comment period on the FDA’s proposed rule to revamp the way that laboratory developed tests (LDTs) are regulated ended on December 4th, 2023. While the FDA has traditionally regulated diagnostic products as medical devices in the U.S.,

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Perficient: Drug Development

JULY 5, 2024

Security and Compliance: ChatBOTs prioritize security and compliance by implementing measures such as encryption, access controls, and adherence to data protection regulations to safeguard user information and ensure privacy. Let’s add a pipeline, Definition will be Pipeline Script. You must add this inside job like the below image.

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Agency IQ

MAY 31, 2024

The legislation further explained that for a certain method to qualify as a “platform technology,” it must demonstrate “reasonable likelihood to bring significant efficiencies to drug development and review processes.” How can sponsors “prove” that these three criteria are met?

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Perficient: Drug Development

NOVEMBER 22, 2023

Compliance and Regulation: Azure AD B2C provides compliance with industry regulations such as GDPR and HIPAA, as well as support for authentication standards like OpenID Connect and OAuth 2.0. This makes it easier for businesses to comply with regulatory requirements and ensure the security of user data.

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Perficient: Drug Development

OCTOBER 7, 2024

However, the new lengthy regulation raised many questions by the industry, and Perficient’s Financial Services Risk and Regulatory consultants have been researching answers and questioning regulators to provide in order to provide our current and future clients the answers to the following questions that have been raised.

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DrugBank

JUNE 27, 2023

The general notion is that patients should be viewed individually, rather than strictly as members of some larger general population, and that their specific genetic background, environment, and lifestyle choices should be considered throughout drug development to the point of treatment and continuing patient care.

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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

SEPTEMBER 1, 2023

For example, in September 2022 the FDA finalized a guidance document on how sponsors of drug product submissions could effectively flag RWE for regulators. Overall, the FDA urged developers to engage with the agency early – including through a Type C meeting – to go over their planned protocol and statistical analysis plan (SAP).

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The Premier Consulting Blog

OCTOBER 26, 2022

During the development cycle of a regulated therapeutic, the transfer of the manufacturing process is inevitable. The process will be transferred from the development lab to a pilot or small-scale manufacturing facility and, if the program is successful, to a facility for commercial manufacturing.

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Agency IQ

JULY 22, 2024

If a drug was previously approved for cancer, but is now approved for a cardiology condition, it would not be considered novel. While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved.

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Agency IQ

JUNE 26, 2023

Because CDx are diagnostic devices, they are not considered part of a combination product but are regulated separately as medical devices. But not all tests and diagnostics used with a drug product are actually CDx.

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Agency IQ

MAY 28, 2024

FDA’s Laboratory Developed Test (LDT) Rule Quick background: The FDA recently published a new final rule to formally extend regulatory oversight over laboratory developed tests (LDTs), which the agency has long maintained are a subset of in vitro diagnostics (IVDs) and therefore should be regulated as a medical device in the U.S.

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Agency IQ

SEPTEMBER 22, 2023

In 1972, when regulatory authority for biologic products was transferred from the National Institutes of Health (NIH) to the FDA, the agency extended the two-study framework to biologic regulation as well. The Heckler case helped to refine the definition of “substantial evidence” in two important ways.

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Agency IQ

DECEMBER 1, 2023

The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion. As before, the guidance provides recommendations on drug development for COVID-19 across five domains: population, trial design, efficacy endpoints, safety considerations and statistical considerations.

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Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? It also contains a definition of the term immunotoxicity— the unintended immunosuppression or stimulation (including hypersensitivity) —which was notably absent from the draft.

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Agency IQ

JUNE 21, 2024

Modeled on the Operation Warp Speed vaccine development communications approach, the pilot aims to test out a rapid communications approach for accelerating rare disease drug development. The idea is that the development challenges faced for a disease which only affects a few hundred patients in the U.S.

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Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more.

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Agency IQ

FEBRUARY 2, 2024

The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. The document has been updated over time to implement advances in understanding cancer and drug development. In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance.

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Agency IQ

APRIL 12, 2024

The regulations also explain that this trait can be demonstrated via appropriate laboratory tests or adequately controlled clinical data. The first (pages 1-5) explains what regenerative medicine products are, provides an overview of what “risk management” means, and cites the requirements that drug developers must satisfy per the U.S.

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