XTalks

APRIL 14, 2021

The color cyan blue is not easy to find in nature, making this discovery significant for the industry’s innovation and developments. Scientists used synthetic biology and computational protein design tools to develop an enzymatic process to transform red cabbage anthocyanins into their desired color. 1, FD&C Blue No.

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The Pharma Data

DECEMBER 30, 2020

We are working quickly on this developing situation and will continue to update the public as new information becomes available. that may contain potentially fatal levels of aflatoxin. that may contain potentially fatal levels of aflatoxin. SILVER SPRING, Md. , This is an ongoing investigation. .”

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. The FDA regularly takes steps to help guide industry through the development process for generic drug products, including combination products, such as MDIs, that consist of a drug and a device.

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FDA Law Blog

APRIL 25, 2023

A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” Section 524B(b)(4) of the FD&C Act authorizes FDA to issue regulations with additional requirements for cyber devices. By Philip Won & Jeffrey K. What’s next?

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The Pharma Data

FEBRUARY 18, 2022

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if: the first two digits of the code are 22 through 37; and the code on the container contains K8, SH or Z2; and the expiration date is 4-1-2022 (APR 2022) or later. and were likely exported to other countries. Source link: [link].

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FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).

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FDA Law Blog

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. By Adrienne R. Section 207 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. Draft Guidance at 8.

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FDA Law Blog

OCTOBER 17, 2021

Perhaps one day those numbers will be as familiar as references to the various parts of the CFR containing the monographs (maybe). The final administrative orders include the same citations to the relevant Federal Register notices that have always been found in the Code of Federal Regulations, but no links. M002) and an Order ID (e.g.,

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Advarra

JULY 19, 2022

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Q: What is your advice for approaching the regulatory strategy?

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FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. 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.

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The Pharma Data

NOVEMBER 26, 2020

We have also launched several new product offerings, most notably a dark chocolate coin (each infused with 20mg CBD) and some skin care/cosmetics selections. for the co-development of a rapid, multiplexed, Novel Coronavirus (COVID-19) test with superior sensitivity and selectivity. . . The Patent, filed with the U.S.P.T.O.

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FDA Law Blog

NOVEMBER 22, 2021

Please see our previous blog postings on various software regulatory developments ( here, here, and here ). This new draft guidance document applies to “device software functions” that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C 17 Act). corrections and removals).

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Pfizer

AUGUST 15, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. FDA Emergency Use Authorization Statement.

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FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

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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 ).

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Pfizer

DECEMBER 13, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. For more information, please visit www.PAXLOVID.com. .

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Pfizer

DECEMBER 20, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. For more information, please visit www.PAXLOVID.com.

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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. Specifically, Type X meetings are limited to: A meeting that is necessary for an otherwise stalled OTC monograph order development program to proceed.

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Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . billion, about 50% was dedicated to regulating medical products, including prescription drugs.

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XTalks

AUGUST 2, 2023

is a global pharmaceutical company, working across both developed and emerging markets. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities. Pfizer Inc.

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Pfizer

NOVEMBER 23, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. Our Commitment to Access. IMPORTANT SAFETY INFORMATION.

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The Pharma Data

DECEMBER 29, 2020

(“Titan” or the “Company”) (TSX: TMD) (Nasdaq: TMDI) , a medical device company focused on the design and development of surgical technologies for robotic single access surgery, announces that the Company has received a written response from the U.S. About Titan Medical. Titan Medical Inc., Enos is a trademark of Titan Medical Inc.

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The Pharma Data

DECEMBER 31, 2020

Hacking – While pharmaceutical companies raced to develop vaccines, hackers furiously worked to steal intellectual property. In December, the European Medicines Agency revealed that documents related to the COVID-19 vaccine developed by Pfizer and BioNTech maintained on the agency’s servers were illegally accessed.

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