Cosmetics, Development and In-Vitro - Clinical Research Informer

Considerations for Mobile Health Technology Developers: Part 1

pharmaphorum

SEPTEMBER 29, 2022

Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. If so, developers must develop and execute on a regulatory strategy. The FDA’s General Approach to Regulating mHealth Products.

Development

Development Regulation Production Life Science

Modernizing The Regulation of Laboratory Developed Tests (LDTs): Senator Rand Paul Identifies A Better Way Forward

FDA Law Blog

JUNE 14, 2021

Shapiro — In our last post on Laboratory Developed Tests (LDTs) , we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation. FDA argues that technological advances in LDTs necessitate FDA’s regulatory oversight pursuant to the Food, Drug, and Cosmetic Act (FDCA). By Jeffrey K.

Regulation

Regulation Development Cosmetics In-Vitro

Transforming Biomanufacturing: Potential of Cell Free Systems

Roots Analysis

AUGUST 15, 2023

Overview of Cell Free Systems Cell-free systems are in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. It is worth mentioning that the first reconstituted system, Protein Synthesis Using Recombinant Elements (PURE) , was developed in 2001.

Protein

Protein In-Vitro Production Reagent

Medical Tourism: Road to Affordable and Quality Medical Care

Delveinsight

JANUARY 6, 2021

As a result of the high healthcare cost, people from developed countries move from their home country to another to receive treatment. As a result of the high healthcare cost, people from developed countries move from their home country to another to receive treatment. What is Medical Tourism?

Cosmetics

Cosmetics In-Vitro Development Vaccination

Cell Free System market: Current Landscape, Growth Opportunities and Future Market Outlook

Roots Analysis

AUGUST 7, 2023

On the other hand, cell free system / cell free expression system are in-vitro platforms that harness the transcription and translation machinery of living cells, in the form of cell lysates, to synthesize various types of biologics, particularly proteins. Interestingly, most of these kits are used for cell-free protein expression.

Marketing

Marketing Protein In-Vitro Production

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. Tobolowsky & Charles G. FDORA § 3209(a)(1). FDORA § 3209(a)(2).

Clinical Trials

Clinical Trials Clinical Trials In-Vivo In-Vitro

HP&M is Pleased to Welcome Lisa Baumhardt (Senior Medical Device Regulation Expert) and Sophia Gaulkin (Associate) to the Firm

FDA Law Blog

NOVEMBER 16, 2021

Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics. Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate.

Regulation

Regulation Compliance In-Vitro Cosmetics

HP&M Files Comments Opposing FDA’s Proposed LDT Rule

FDA Law Blog

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. As a threshold matter, FDA lacks the power to regulate tests developed and used in a laboratory. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

Regulation

Regulation Genetics Cosmetics Compliance

A VALID Argument: Proposed Legislation Would Reshape Regulation of Diagnostics

FDA Law Blog

JULY 8, 2021

Javitt — For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). Enter Congress, and the introduction on June 24 of newest incarnation of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act.

Regulation

Regulation In-Vitro Production Genetics

New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

OCTOBER 27, 2022

These risks have resulted in many companies being found in breach of self-regulatory codes, and a view that an increasingly narrow interpretation was being taken by authorities. What is the scope of the Guidance? Companies should ensure key words are appropriate and do not constitute unauthorised promotion to the public.

Life Science

Life Science Compliance Regulation Cosmetics

FDA’s Summer Plans May Include LDT Rulemaking

FDA Law Blog

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. The Notice of Proposed Rulemaking (NPRM) for LDTs is scheduled to be published in the Federal Register in August. Whether we will actually see a proposed rule in August is more than a little uncertain, however.

Regulation

Regulation Cosmetics In-Vitro Development

Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

Pfizer

AUGUST 15, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1

Drugs

Drugs Vaccination Vaccine In-Vitro

Considerations for Mobile Health Technology Developers: Part 2

pharmaphorum

OCTOBER 4, 2022

The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) were considered. Part 2 of this series is devoted to clinical decision support (CDS) software.

Development

Development Regulation Cosmetics Life Science

Laboratory Developed Tests: Members of Congress Ask FDA to Do Their Job for Them

FDA Law Blog

MAY 17, 2021

You may recall that last summer (on August 19), the Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to cease premarket review of laboratory developed tests (LDTs), including COVID?19 At the time, we wrote favorably about this move. Put bluntly, the review of COVID?19

Development

Development Cosmetics Regulation In-Vitro

Laboratory Developed Tests: Members of Congress Ask FDA to Do Their Job for Them

FDA Law Blog

MAY 17, 2021

Shapiro — You may recall that last summer (on August 19), the Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to cease premarket review of laboratory developed tests (LDTs), including COVID?19 At the time, we wrote favorably about this move. Put bluntly, the review of COVID?19

Development

Development Cosmetics Regulation In-Vitro

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

Regulation

Regulation In-Vitro Manufacturing Licensing

Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law Blog

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.

In-Vitro

In-Vitro Regulation Production Compliance

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

DECEMBER 13, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1,

Drugs

Drugs Licensing Licensing Production

FDA Phones a Friend: Joint Statement with CMS Eschews CLIA Modernization and Supports FDA Oversight of LDTs

FDA Law Blog

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

Regulation

Regulation Radiology Cosmetics Compliance

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

DECEMBER 20, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Tuesday, December 20, 2022 - 04:30pm. NEW YORK, December 20, 2022 -- Pfizer Inc.

Drugs

Drugs Licensing Licensing Containment

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Pfizer

NOVEMBER 23, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). This agreement will supply participating countries up to 3.4 million treatment courses upon orders being placed.

Licensing

Licensing Licensing Drugs Manufacturing

Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

FDA Law Blog

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 Confirmatory Evidence Guidance, available here ) had appeared on CDER’s Guidance Agenda for the past three years.

Drugs

Drugs Development Trials In-Vitro

Is Confirmatory Evidence Having a Moment?

FDA Law Blog

OCTOBER 11, 2022

We use the term “confirmatory evidence” as short-hand for one of the two ways explicitly defined in the Federal Food Drug & Cosmetic Act (“FD&C Act”) for demonstrating substantial evidence of effectiveness. More importantly, replication is but one means to substantiate the results of a clinical investigation or scientific study.

Clinical Trials

Clinical Trials Clinical Trials Drugs Trials

MedTech Conference Download

FDA Law Blog

NOVEMBER 8, 2022

This allows FDA to further engage with international members, address harmonization of international standards, develop multilateral agreements and cross agency documents around AI/ML and a predetermined control plan (PCCP), and converge on topics such as AI/ML. In response, Ms. This includes EUAs and full marketing authorizations.

Regulation

Regulation In-Vitro Production Marketing

Clinical Research Informer

Considerations for Mobile Health Technology Developers: Part 1

Modernizing The Regulation of Laboratory Developed Tests (LDTs): Senator Rand Paul Identifies A Better Way Forward

Trending Sources

Transforming Biomanufacturing: Potential of Cell Free Systems

Medical Tourism: Road to Affordable and Quality Medical Care

Cell Free System market: Current Landscape, Growth Opportunities and Future Market Outlook

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

HP&M is Pleased to Welcome Lisa Baumhardt (Senior Medical Device Regulation Expert) and Sophia Gaulkin (Associate) to the Firm

HP&M Files Comments Opposing FDA’s Proposed LDT Rule

A VALID Argument: Proposed Legislation Would Reshape Regulation of Diagnostics

New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

FDA’s Summer Plans May Include LDT Rulemaking

Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

Considerations for Mobile Health Technology Developers: Part 2

Laboratory Developed Tests: Members of Congress Ask FDA to Do Their Job for Them

Laboratory Developed Tests: Members of Congress Ask FDA to Do Their Job for Them

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

Proposed LDT Rule Raises Many Questions but Provides Few Answers

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

FDA Phones a Friend: Joint Statement with CMS Eschews CLIA Modernization and Supports FDA Oversight of LDTs

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

Is Confirmatory Evidence Having a Moment?

MedTech Conference Download

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