Cosmetics, Generic Drugs and Marketing - Clinical Research Informer

FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters

FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

Generic Drugs

Generic Drugs Manufacturing Drugs Cosmetics

ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law Blog

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

Cosmetics

Cosmetics Compliance Generic Drugs Regulation

FDA Approves First Generic of Symbicort to Treat Asthma and COPD

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. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

FDA Approval

FDA Approval Generic Drugs Production Drugs

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3. and PART 3½)

FDA Law Blog

MARCH 13, 2024

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the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). Lehman , No. 95-650-A (E.D. . 10,544,220 (the ‘220 patent). Exhibit 3.

Marketing

Marketing Production FDA Approval Generic Drugs

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S. Both bills – S.

Generic Drugs

Generic Drugs Drugs Branding Production

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S. Both bills – S.

Generic Drugs

Generic Drugs Drugs Branding Production

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks. More than a few have taken far longer—literally decades.

FDA Approval

FDA Approval Production Drugs Generic Drugs

In the News: August 2021 Regulatory and Development Updates

Camargo

SEPTEMBER 8, 2021

The drugs approved via PANDAs are often used as the reference listed drug (RLD) for ANDAs under 505(j), and they can also be used as the listed drug for 505(b)(2) applications. PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA.

Development

Development Regulation Production Drugs

Prescription Drug User Fees Ex-PAND-ed to PANDAs (PANDA-monium Part II)

FDA Law Blog

JUNE 2, 2022

Since 1984, generic drugs have been approved under ANDAs pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA); before 1984, no formal mechanism for an ANDA existed so FDA used sections 505(b) and 505(c) to approve follow-on drugs based on the Agency’s previous findings of safety and efficacy.

Drugs

Drugs Production Generic Drugs Cosmetics

Zootechnical Animal Food Substances; a New Category of Animal Food Additives Proposed

FDA Law Blog

JUNE 28, 2023

1844 – Animal Drug and Animal Generic Drug User Fee Amendments of 2023. The proposed legislation appears to be an effort to resolve issues created by FDA’s Center for Veterinary Medicine’s (CVM) interpretation of the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of food.

Regulation

Regulation Drugs Production Generic Drugs

Teva Announces Launch of an Authorized Generic of Epiduo® Forte Gel (adapalene and benzoyl peroxide gel 0.3%/2.5%), in the U.S.

The Pharma Data

DECEMBER 4, 2021

The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. Currently, 1 in 11 generic prescriptions dispensed in the U.S.

Doctors

Doctors Doctor Medicine Production

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

Production

Production Insulin Branding Generic Drugs

It’s PANDA-monium at FDA

FDA Law Blog

AUGUST 16, 2021

A PANDA, or the Pre-Hatch-Waxman Abbreviated New Drug Application, refers to abbreviated drug applications submitted and approved under sections 505(b) and 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA) prior to the enactment of the Hatch-Waxman Amendments in 1984, as FDA announced in the Federal Register last week.

Production

Production Drugs Generic Drugs Cosmetics

Hitting Pause on Criticism of the FDA, Just for Today

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. . There are 19,000 approved prescription drugs for marketing in the U.S. Far from it.

Generic Drugs

Generic Drugs Manufacturing Regulation Drugs

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. 2022 Revenue: Pfizer reported an annual revenue of $100.33 Pfizer Inc.

Sales

Sales Manufacturing FDA Approval Life Science

Proposed Legislation Would Reverse Genus Decisions

FDA Law Blog

MARCH 29, 2022

Koblitz — Legislation has been proposed in Congress that would require FDA to regulate all contrast agents as drugs even though two courts determined that doing so clearly contradicts the plain language of the Federal Food Drug and Cosmetic Act (“FDC Act”).

Regulation

Regulation Production Drugs Generic Drugs

Shkreli is sued for monopolizing Daraprim. But what ever happened to Azar’s single source drug import plan?

Pharmacy Checkers

JANUARY 30, 2020

Pasted from the AG’s press release : Attorney General James Sues ‘Pharma Bro’ Martin Shkreli And Vyera Pharmaceuticals For Illegally Monopolizing Life-Saving Drug. Basically, the charge is that the Vyera took myriad actions to prevent a lower-cost generic drug from coming to market.

Drugs

Drugs Generic Drugs Cosmetics FDA Approval

Clinical Research Informer

FDA Sort-of Commits to Meet with Generic Drug Manufacturers that Have Received Warning Letters

ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

Trending Sources

FDA Approves First Generic of Symbicort to Treat Asthma and COPD

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3. and PART 3½)

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA-Approved Labeling: Is Enough Enough?

In the News: August 2021 Regulatory and Development Updates

Prescription Drug User Fees Ex-PAND-ed to PANDAs (PANDA-monium Part II)

Zootechnical Animal Food Substances; a New Category of Animal Food Additives Proposed

Teva Announces Launch of an Authorized Generic of Epiduo® Forte Gel (adapalene and benzoyl peroxide gel 0.3%/2.5%), in the U.S.

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

It’s PANDA-monium at FDA

Hitting Pause on Criticism of the FDA, Just for Today

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

Proposed Legislation Would Reverse Genus Decisions

Shkreli is sued for monopolizing Daraprim. But what ever happened to Azar’s single source drug import plan?

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