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

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

Pfizer

DECEMBER 13, 2022

In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID for patients who are at high risk of progression to severe disease from COVID-19. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in February 2023.

Drugs 110

Drugs Licensing Licensing Production 110

FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. Tobolowsky & Charles G. FDORA § 3209(a)(1). FDORA § 3209(a)(2). 42 U.S.C. § 42 U.S.C. §

Clinical Trials 64

Clinical Trials Clinical Trials In-Vivo In-Vitro 64

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 40

Regulation Compliance In-Vitro Cosmetics 40

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 52

Development Cosmetics Regulation In-Vitro 52

FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. There is much to unpack, and we intend to do so in a series of blog posts.

In-Vitro 64

In-Vitro Regulation Production Compliance 64

FDA Law Blog

OCTOBER 11, 2022

Valentine — As we begin the final quarter of 2022 and the leaves here on the east coast begin to turn and fall, it seems the clock may be running out on FDA and the Center for Drug Evaluation and Research (CDER) to meet its goal of publishing a draft guidance on confirmatory evidence this year.

Clinical Trials 61

Clinical Trials Clinical Trials Drugs Trials 61

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). The bill creates a new category, called In Vitro Clinical Tests (IVCTs), which encompasses both distributed IVD products and laboratory tests.

Regulation 52

Regulation In-Vitro Production Genetics 52

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 64

Drugs Development Trials In-Vitro 64

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. Circuit rejected FDA’s claim that it could regulate, at its discretion, any medical device as a drug. Add one more to that tally.

Regulation 40

Regulation Production Drugs In-Vitro 40

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 40

Development Cosmetics Regulation In-Vitro 40

FDA Law Blog

FEBRUARY 4, 2024

The joint press release provides support for the adage that “opposites attract”; FDA claims broad authority to regulate LDTs notwithstanding its lack of statutory authority under the Federal Food, Drug, and Cosmetic Act, while CMS disavows the clear authority over clinical laboratory testing with which it has long been imbued under CLIA.

Regulation 59

Regulation Radiology Cosmetics In-Vitro 59

FDA Law Blog

DECEMBER 6, 2023

The Federal Food, Drug, and Cosmetic Act simply did not confer that power upon FDA. Javitt — On Monday, Hyman, Phelps & McNamara, P.C. 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.

Regulation 59

Regulation Genetics Cosmetics In-Vitro 59

Pfizer

NOVEMBER 23, 2022

(NYSE: PFE) today announced an agreement with the European Commission (EC) to supply its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to countries participating in the Joint Procurement Agreement across Europe. This agreement will supply participating countries up to 3.4

Licensing 40

Licensing Licensing Drugs Manufacturing 40

FDA Law Blog

JUNE 19, 2023

In the most recent Unified Agenda, which is a list of planned regulatory actions published semi-annually by the Office of Management and Budget (OMB), FDA announced its intent to issue a proposed rule “to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.”

Regulation 56

Regulation Cosmetics In-Vitro Development 56

FDA Law Blog

NOVEMBER 8, 2022

To put it into perspective, these were the numbers (so far) for in vitro diagnostics EUAs: 304 molecular, 84 antibody, 51 antigen, and 5 other. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). In response, Ms. This includes EUAs and full marketing authorizations.

Regulation 59

Regulation In-Vitro Production Marketing 59