The Pharma Data

MAY 3, 2021

Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Continuous professional development. The results demonstrate that regulatory knowledge and qualifications are an advantage and of value in personal and professional development.

Development 52

Development Contamination In-Vitro Production 52

Roots Analysis

SEPTEMBER 4, 2024

The main purpose of in vitro diagnostic solutions is to perform non-invasive / minimally invasive test procedures in order to detect a variety of health conditions using samples, such as blood, tissue or urine. Such tests help to diagnose health conditions, monitor treatments, perform disease screening and aid in early diagnosis of diseases.

Marketing 40

Marketing In-Vitro Compliance Development 40

FDA Law Blog

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. While at FDA, Ms. During her FDA tenure, Ms. Gibbs , HP&M Director.

In-Vitro 59

In-Vitro Engineer Production Regulation 59

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 ).

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

The Pharma Data

JANUARY 27, 2021

BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments in mental disorders and viral infections, announces it has entered into an agreement with Eurofins Discovery for TD-0148A’s U.S. VANCOUVER, Jan.

In-Vitro 52

In-Vitro Containment Drugs Production 52

pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. What is the scope of the Guidance? Companies can sponsor website content if the role of the company is made clear.

Life Science 98

Life Science Medicine Regulation Compliance 98

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 advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. In the pre-market area, Ms. In addition, Ms.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

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 64

In-Vitro Regulation Production Compliance 64

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 ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

In-Vitro 69

In-Vitro Regulation Production Development 69

XTalks

JUNE 30, 2023

But to meet aggressive milestones and stringent performance standards, there’s a need for continuous innovation and streamlined development and quality control workflows. Sartorius is a globally recognized player in the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers.

In-Vitro 52

In-Vitro Manufacturing Production Antibody 52

The Pharma Data

NOVEMBER 17, 2021

Streamlined in vitro data, published in bioRxiv, demonstrate that sotrovimab retains exertion against all current variants of concern and interest of the SARS-CoV-2 contagion as defined by the World Health Organization, plus others, including, but not limited to, Delta (B.1.617.2), 1.617.2), Delta Plus (AY.1 2) and Mu (B.1.621).

Antibody 52

Antibody In-Vitro Vaccine Vaccination 52

FDA Law Blog

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. SCF : LDT, unmet need within an integrated healthcare system.

Regulation 64

Regulation Manufacturing Production Compliance 64

The Pharma Data

OCTOBER 27, 2020

The test is planned for commercial launch as a CE-IVD ( in vitro diagnostic) certified product in the European Union in Q1 2021. “Applying 3a’s proprietary enhanced RNA technology to PCR testing was a logical next step in our product development pipeline,” said Dr. .

RNA 52

RNA Drug Delivery Production In-Vitro 52

The Pharma Data

JANUARY 16, 2021

It has become the de facto standard equipment for high titer transient protein expression platforms used by many leading Chinese antibody drug pharmaceutical companies and IVD (In Vitro Diagnostics) companies since its launch in Oct. Etta Biotech is a leading cell electroporation technology and equipment supplier. JS Bio’s parent company.

Protein 52

Protein Production Antibody In-Vitro 52

Advarra

APRIL 19, 2023

In vitro diagnostic (IVD) devices are tests used on human biospecimens (e.g., IVDs meeting this definition are known as laboratory developed tests (LDTs). The developer/manufacturer of the IVDs are typically the entity that submits the study. IVDs are used in almost all clinical research.

Research 52

Research Regulation Clinical Trials Clinical Trials 52

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 59

Regulation Genetics Cosmetics In-Vitro 59

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. In other words, what are the risks and benefits of the product? The greater the risk, the more likely a series of trials for market clearance or approval will be required.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

Advarra

AUGUST 31, 2022

If a new medical device, software as a medical device (SaMD), or in vitro diagnostic (IVD) is poised to successfully make it through the development process to commercialization, sponsors must consider a trifecta of interconnected systems involving: Regulatory strategy and submissions. Quality assurance and risk management.

Research 52

Research Regulation Clinical Trials Clinical Trials 52

XTalks

JUNE 12, 2023

These powerhouse organizations have not only distinguished themselves through their cutting-edge devices and technologies but also via their robust research and development (R&D) capabilities, unwavering commitment to quality and extensive global reach. 1) Medtronic 2022 Revenue: Medtronic reported an annual revenue of $31.69

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

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 59

Regulation Radiology Cosmetics In-Vitro 59

Advarra

JULY 18, 2023

Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) requirements ( 21 CFR 812 ). When an investigational device does not carry this potential for serious risk, the clinical investigation is NSR.

Research 52

Research Clinical Trials Clinical Trials Trials 52

FDA Law Blog

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Regulation 52

Regulation In-Vitro Development Radiology 52

The Pharma Data

NOVEMBER 4, 2020

CENTOGENE’s SARS-CoV-2 test is a molecular diagnostic test performed for the in vitro qualitative detection of RNA from the SARS-CoV-2 in oropharyngeal samples from presymptomatic patients and probands according to the recommended testing by public health authority guidelines. CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Nov.

Genetics 40

Genetics In-Vitro Biobanking Containment 40

Roots Analysis

OCTOBER 19, 2023

Bacteria plays a crucial role in maintaining the ecosystem balance. However, there are few species of bacteria that can cause several infectious diseases ( such as strep throat, salmonellosis, tuberculosis, whooping cough ). These are mainly transmitted through air, water, living organisms, and food.

Bacteria 40

Bacteria Production In-Vivo In-Vitro 40

The Pharma Data

MARCH 17, 2021

Overall, patient compliance for PROs was greater than 90 percent. The PRO analysis included patients in both arms of the study and measured their experiences with side effects, symptoms, and health-related quality of life, in those receiving Verzenio plus ET versus ET alone. The detailed data were presented at the virtual 17th St.

HR 52

HR Trials In-Vitro Manufacturing 52

FDA Law Blog

FEBRUARY 20, 2025

Gibbs The multi-decade battle over FDAs power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week. Citing the May 6 compliance date for Stage 1 of the LDT Rule, both ACLA and AMP asked that Judge Jordan issue his ruling expeditiously. By Allyson B. Mullen & Jeffrey N.

In-Vitro 102

In-Vitro Regulation Compliance Radiology 102