FDA Law Blog

APRIL 19, 2021

FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.

Regulation 40

Regulation Production Drugs In-Vitro 40

Pharmaceutical Technology

JULY 15, 2022

Despite entering its fourth decade of availability, in vitro fertilization (IVF), a medical technique used to facilitate the conception of a baby for those facing fertility problems, remains an elusive dream for many. Fairtility also claims the product reduces the time taken for each IVF cycle by 30 hours. in 2000 to 12.3%

In-Vitro 264

In-Vitro Production Regulation Research 264

pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. 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. Food and Drug Administration (FDA) regulation as a medical device.

Development 103

Development Regulation Production Life Science 103

Drug Discovery World

OCTOBER 2, 2023

Karikó and Weissman noticed that dendritic cells recognise in vitro transcribed mRNA as a foreign substance, which leads to their activation and the release of inflammatory signalling molecules. The effect was due to the reduced activation of an enzyme that regulates protein production. Image credit: Ill.

In-Vitro 64

In-Vitro Protein Vaccination Vaccine 64

Drug Discovery World

JANUARY 17, 2024

This anchoring regulates metabolism and mitochondrial morphology. Likewise, human cells with a mutated MFN2 gene exhibited similar traits, as well as abnormalities in mitochondrial fission and lower energy (or ATP) production, indicating problems in the generation of ‘cellular energy’.

In-Vitro 52

In-Vitro Regulation Protein Gene 52

FDA Law Blog

MAY 25, 2022

It is not uncommon for some in vitro diagnostic tests to suffer from poor positive predictive value, in part due to the rarity of the disease. Our readers will recall that this report was issued shortly after FDA’s release of its draft guidance documents seeking to regulate laboratory developed tests.

Regulation 40

Regulation Genetics In-Vitro Development 40

FDA Law Blog

OCTOBER 24, 2023

It includes questions, text, logic, and prompts, and integrates databases such as FDA product codes and FDA-recognized voluntary consensus standards. It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents.

In-Vitro 52

In-Vitro Regulation Production 52

FDA Law Blog

SEPTEMBER 27, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. The program began accepting proposals on September 7, 2022, from manufacturers that have existing technologies and can scale production, while meeting FDA quality requirements.

In-Vitro 59

In-Vitro Manufacturing Antibody Regulation 59

XTalks

JANUARY 29, 2024

Although the medical device industry is dedicated to advancing healthcare innovation, pursuing environmental responsibility has encountered obstacles mainly due to rigorous regulations. Coloplast’s product portfolio includes Ostomy Care, Continence Care, Wound and Skin Care, Interventional Urology and Voice and Respiratory Care.

Packaging 64

Packaging Packaging Production In-Vitro 64

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

FDA Law Blog

MARCH 16, 2023

Baumhardt, Senior Medical Device Regulation Expert — On March 8th FDA granted Quidel’s Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. The authorization of this De Novo, with a formal classification of Class II, now opens the door for follow-up 510(k) submissions that declare this product as their predicate.

Marketing 40

Marketing In-Vitro Regulation Reagent 40

XTalks

JUNE 30, 2023

Sartorius is a globally recognized player in the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers. Sartorius understands the need for continuous innovation in the highly regulated and price-sensitive diagnostics market. Banczyk has expertise in medical and IVD filtration devices.

In-Vitro 52

In-Vitro Manufacturing Production Antibody 52

FDA Law Blog

APRIL 24, 2024

The meetings have presented a mix of views with some organizations meeting with OMB being in favor of FDA regulation and others being very much opposed. The final rule was identified by OMB as Section 3(f)(1) significant meaning that the rule “may have an annual effect on the economy of $200 million or more. ;

Regulation 59

Regulation In-Vitro Production 59

pharmaphorum

OCTOBER 27, 2022

The Guidance applies to both product-related and therapeutic-area-related activities. Why is guidance needed? Uses of social media is continually expanding and it has been difficult for companies to apply general advertising rules and guidance to the modern world. What is the scope of the Guidance?

Life Science 98

Life Science Compliance Regulation Cosmetics 98

Advarra

SEPTEMBER 23, 2022

Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : . The Food and Drug Administration (FDA) is the federal entity in the U.S. When Does an IND go into Effect? . The IND goes into effect; and .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Drug Discovery World

SEPTEMBER 28, 2023

Earlier this year, we explored the microbiome and its role in drug development across various therapeutic areas. This article will focus on one such area of great unmet need and promise: women’s health. This is likely in part because their byproduct, lactic acid, is known to inhibit pathogenic bacteria 25.

Clinical Trials 64

Clinical Trials Clinical Trials Regulation Bacteria 64

Drug Discovery World

DECEMBER 8, 2023

It’s true that both general and vertical AI tools can make businesses more efficient but only vertical AI will enable a reduction in costs, improve operational efficiencies and productivity, and produce high-quality cell and gene therapy programs. The cell and gene therapy industry is no exception to this digital transformation.

Gene Therapy 64

Gene Therapy Gene In-Vitro Development 64

FDA Law Blog

DECEMBER 13, 2022

Gibbs — It is widely expected that the fate of the VALID Act – and therefore the world of diagnostic regulation – will be determined in the next two weeks (see our previous post here ). Javitt & Jeffrey N. This is not a trivial matter. Telehealth has become increasing important to the health care system. Emphasis added).

In-Vitro 72

In-Vitro Containment Manufacturing Regulation 72

Roots Analysis

JANUARY 14, 2024

Overview of Biologics Biologics refer to medicinal / therapeutic products that are either manufactured using living organisms or semi-synthesized from biological sources. Like all drugs, biologics are regulated by the FDA. This can be attributed to the fact that the production of biopharmaceuticals requires living expression systems.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Protein Bacteria 40

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. Meeting with the Regulators. Intended use.

Research 52

Research Regulation Clinical Trials Clinical Trials 52

FDA Law Blog

JUNE 22, 2023

Mullen — FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. The first OTC IVD cleared by FDA was a qualitative dipstick urine glucose test in 1977, followed shortly thereafter by the first OTC pregnancy test clearance in 1978.

In-Vitro 59

In-Vitro Manufacturing Regulation Drugs 59

pharmaphorum

MARCH 4, 2021

In a separate announcemen t, the UK’s Medicines and Healthcare products Regulatory Authority (MHRA), issued guidance outlining plans to fast-track modified vaccines for new coronavirus variants. The guidance comes from the ACCESS Consortium of regulators from the UK, Australia, Canada, Singapore and Switzerland.

Vaccination 104

Vaccination Vaccine Development Life Science 104

The Pharma Data

DECEMBER 14, 2020

. Product type: Nucleic acid testing (NAT) technologies that use real-time polymerase chain reaction (RT-PCR) for detection of SARS-CoV-2. Purpose of this notice : To ensure users of certain nucleic acid testing (NAT) technologies are aware of certain aspects of the instructions for use (IFU) for all products.

Reagent 52

Reagent In-Vitro Production Regulation 52

The Pharma Data

JANUARY 16, 2021

Etta Biotech”), to set up a high titer transient protein expression platform for high quality protein production using JS Bio’s transient transfection media. The two parties also plan to join force further to build a rapid protein production platform aiming at producing gram-scale protein for R&D, e. JS Bio’s parent company.

Protein 52

Protein Production Antibody In-Vitro 52

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. Heinrich Jehle, managing director of 3a-Diagnostics.

RNA 52

RNA Drug Delivery Production In-Vitro 52

Drug Discovery World

MAY 25, 2023

The aim of the researchers is to understand the mechanisms that regulate cancer cell proliferation, survival and dissemination; to identify critical components of these pathways as targets for novel cancer therapies; and to help translate this knowledge to patient benefit. Phenotyping, in contrast, can produce a hit/lead without a target.

Research 52

Research Drugs In-Vitro Insulin 52

The Pharma Data

MAY 3, 2021

Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . . Continuous professional development. DiMichele provides valuable information on some of the available programs. . .

Development 52

Development Contamination In-Vitro Production 52

FDA Law Blog

JANUARY 3, 2022

There are multiple explanations for the current inadequate number of tests ( link ), including government policies on test procurement, manufacturers’ decisions to curtail production when demand fell this summer, the extraordinarily rapid spread of the omicron variant, and surges in demand brought on by the holidays.

In-Vitro 52

In-Vitro Regulation Manufacturing Development 52

The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Previously, he held roles as CMO at Trimeris Inc.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

Drug Discovery World

MAY 16, 2023

The deeper the understanding of product and process from a characterisation standpoint, the smoother the regulatory conversations and development pathway will be.” What are the global innovations in cell and gene therapy? What opportunities and challenges are emerging and can therapies get to market faster? DDW’s Megan Thomas finds out.

Gene Therapy 52

Gene Therapy Gene Manufacturing Marketing 52

FDA Law Blog

JANUARY 3, 2022

There are multiple explanations for the current inadequate number of tests ( link ), including government policies on test procurement, manufacturers’ decisions to curtail production when demand fell this summer, the extraordinarily rapid spread of the omicron variant, and surges in demand brought on by the holidays.

In-Vitro 52

In-Vitro Manufacturing Regulation Development 52

XTalks

SEPTEMBER 30, 2020

Type I interferons are critical molecular immune regulators that are at the forefront of antiviral responses early in an infection. The two studies were recently published online in the journal Science, both of which were led by Jean-Laurent Casanova, an infectious disease geneticist at Rockefeller University. percent of women and 12.5

Antibody 135

Antibody Genetics Research In-Vitro 135

FDA Law Blog

AUGUST 3, 2022

Thirty years ago today, FDA announced that it had the authority to regulate you. Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. Mullen — Happy Birthday Laboratory Developed Tests (LDTs). 92P-0405 (Aug.

In-Vitro 98

In-Vitro Regulation Compliance Production 98

Pfizer

AUGUST 15, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms. FDA Emergency Use Authorization Statement. AUTHORIZED USE.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

Pfizer

JANUARY 27, 2023

This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.

Marketing 75

Marketing Production Drugs Licensing 75

The Pharma Data

JULY 23, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Roche’s Chief Medical Officer and Head of Global Product Development. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. About Ronapreve (casirivimab and imdevimab).

Antibody 52

Antibody Medicine Production In-Vitro 52

FDA Law Blog

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

In-Vitro 69

In-Vitro Regulation Production Development 69