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 96

Development Regulation Production Life Science 96

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

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

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

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

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

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. 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 ). Gaulkin & Jeffrey N.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81