Delveinsight

FEBRUARY 22, 2021

opaque, contain zinc oxide or titanium dioxide, and may be cosmetically unacceptable to some patients. The drug works by increasing skin pigmentation, which provides protection and improves sun tolerance. . Nevertheless, approval of scenesse gave the EPP market size growth a significant push. EPP patients with end?stage

Marketing 52

Marketing Research Cosmetics Gene 52

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the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). Do you really have to identify both “Grants” to be correct? Lehman , No.

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

XTalks

NOVEMBER 24, 2022

Earlier this week, the US Food and Drug Administration (FDA) sent out warning letters to five companies illegally selling CBD-infused food and beverage products. According to the warning letters, these products are considered adulterated under “section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C.

Production 52

Production Branding Cosmetics Marketing 52

FDA Law Blog

MAY 6, 2024

The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C). In addition, manufacturers need to submit plans for monitoring, identifying, and addressing post market cybersecurity vulnerabilities. are cybersecure.

Manufacturing 105

Manufacturing Cosmetics Regulation Containment 105

FDA Law Blog

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. DASCA became law, amending the CSA, on December 18, 2014.

Hormones 52

Hormones Manufacturing Regulation Drugs 52

XTalks

SEPTEMBER 28, 2023

One of the reasons behind this gap is the US Food and Drug Administration’s (FDA) “ generally recognized as safe ” — or GRAS — designation. This meant manufacturers could skip the FDA’s exhaustive safety review process, ensuring their products reached the market faster. BVO tends to accumulate in the human body.

Hormones 52

Hormones Containment Production Cosmetics 52

FDA Law Blog

APRIL 21, 2024

Taiho’s counsel quickly followed up with a letter to FDA and a supplemental submission to the PTO in February 2024 arguing otherwise: “[P]ermission for commercial marketing” was not effective under the September 30, 2022 FDA letter because the product would have been misbranded if marketed thereunder. sections 331(a) and 352.(a)(l),

Production 59

Production FDA Approval Marketing Cosmetics 59

FDA Law Blog

APRIL 19, 2023

If that language sounds familiar, that’s because it is very similar to the language used to describe the process by which FDA determines that a new drug application (NDA) will be filed (or not). Reminders of the need to fulfill existing environmental assessment requirements and make all submissions electronically are also included.

Containment 59

Containment Drugs Cosmetics Marketing 59

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

Development 161

Development Production Immune Response Licensing 161

FDA Law Blog

JUNE 28, 2023

ASCA was authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). For testing conducted under ASCA, the FDA will have confidence in the testing laboratories’ test methods and results and does not intend to request additional information regarding testing methodologies.

Containment 52

Containment Radiology Cosmetics Manufacturing 52

FDA Law Blog

OCTOBER 17, 2021

As part of the process of moving from the old rule-based monograph system to an administrative order framework, the CARES Act provides that in most cases a final monograph or tentative final monograph that establishes conditions of use for a drug described in section 505G(a)(1) or (2) of the FD&C Act is “deemed to be a final order”.

Containment 52

Containment Drugs Production Cosmetics 52

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 52

FDA Approval Generic Drugs Production Drugs 52

The Pharma Data

DECEMBER 4, 2021

The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. Continuing to advance and launch much-needed generic drugs is critical to ensuring access to quality medicines to everyone who needs them.” You are encouraged to report side effects of prescription drugs to the FDA. About Teva.

Doctors 52

Doctors Doctor Medicine Production 52

FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.

Production 59

Production Drugs FDA Approval Compliance 59

The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). million and US$1.8 million. . Juyou Bio-Technology Co.,

Licensing 40

Licensing Licensing Dermatology Production 40

XTalks

APRIL 14, 2021

The US Food and Drug Administration (FDA) defines color additives as “any substance that imparts color to a food, drug, cosmetic, or the human body. After some research, they discovered that the treats did not look as vibrant as other children’s gummy snacks sold in the market.

Regulation 94

Regulation Production Branding Cosmetics 94

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).

Drugs 69

Drugs Licensing Licensing Containment 69

FDA Law Blog

NOVEMBER 22, 2021

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). It does not apply to software-related documentation that may be needed to evaluate post market software device issues (e.g.,

Containment 52

Containment Production Cosmetics Development 52

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

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The state of current scientific knowledge regarding the drug.

FDA Approval 69

FDA Approval Drugs Containment Cosmetics 69

FDA Law Blog

JULY 26, 2022

Like all Guidance documents, it starts out with background, explaining that the Orange Book is FDA’s list of drug products approved under the Federal Food, Drug, and Cosmetic Act and contains patent and exclusivity information related to such products.

Production 52

Production Sales Drugs Cosmetics 52

Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

Generic Drugs 68

Generic Drugs Manufacturing Regulation Drugs 68

The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., Unrealized gain (loss) on marketable equity securities.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Dermatology 52

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. It contains the antiviral medications nirmatrelvir and ritonavir.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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

The Pharma Data

DECEMBER 28, 2020

About ALKS 3831 (olanzapine/samidorphan) ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. . DUBLIN , Dec. 1 American Psychiatric Association.

Drugs 40

Drugs Manufacturing Clinical Trials Clinical Trials 40

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

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.

Regulation 45

Regulation Production Cosmetics Sales 45

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.

Manufacturing 52

Manufacturing Packaging Packaging Production 52

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

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

The Pharma Data

DECEMBER 29, 2020

Food & Drug Administration (“FDA”) to its Request for Information in accordance with Section 513(g) of the U.S. Federal Food, Drug and Cosmetic Act (“FD&C Act”), regarding the regulatory requirements applicable to its robotically assisted surgical device (“RASD”), the Enos Robotic Single Access System. “The

Containment 40

Containment Marketing Development Cosmetics 40

Pharmacy Checkers

DECEMBER 20, 2019

The FDA has done something that prescription drug importation advocates had possibly given up on. The agency drafted a new proposed rule to allow importation from Canada of lower-cost drugs and industry guidance for drug manufacturers to import their FDA-approved foreign drug versions, for which they can charge lower prices.

Drugs 73

Drugs FDA Approval Cosmetics Pharmacy 73