Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

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Drugs Licensing Licensing Containment 69

Camargo

AUGUST 22, 2021

The first two were published in December of 2014: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act mandates that NDAs, ANDAs, and INDs be submitted in electronic format. The FDA published three binding guidance documents regarding the TRC. Code 1734.

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Containment Bioavailability Cosmetics Packaging 190

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 21, 2024

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. Subpart B – Supplemental Provisions Subpart B – Supplemental Provisions, adds requirements related to control of records (new § 820.35) and device labeling and packaging controls (new § 820.45). Revised § 820.3

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Regulation Manufacturing Packaging Packaging 59

FDA Law Blog

JUNE 12, 2023

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. By Riëtte van Laack — FDA regulates pet food similar to other animal foods.

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Regulation Production Cosmetics Sales 45

XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir.

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Sales Manufacturing FDA Approval Life Science 98

FDA Law Blog

FEBRUARY 15, 2022

OTC monograph order requests or OMORs), other matters relevant to the regulation of nonprescription drugs, and the development of new nonprescription drugs under section 505G. To issue guidance that specifies the procedures and principles for formal meetings between FDA and meeting requesters for OTC monograph drugs.

Cosmetics 40

Cosmetics Drugs Development Regulation 40

Pfizer

NOVEMBER 23, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Sufficient information is not available to assess for a potential drug interaction. Our Commitment to Access. AUTHORIZED USE.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

FDA Law Blog

MARCH 6, 2022

FDA investigators expecting to see detailed procedures setting forth each of the requirements of the QSR have been confounded by procedures containing different terminology or lacking elements specifically required by the QSR. The proposed QMSR includes sections on control of records and device labeling and packaging controls.

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Regulation Compliance Manufacturing Packaging 52

FDA Law Blog

NOVEMBER 14, 2022

2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). FDA is authorized to charge an annual facility fee for OTC monograph drug facilities. Size, revenue, and number of finished drug products manufactured at a facility do not affect the OMUFA facility fee.

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Manufacturing Packaging Packaging Production 52