My Local Study

APRIL 28, 2023

Food, Drug, and Cosmetic Act, established in 1938, helped set the standard for research studies today, shaping how medications and treatments are evaluated and released. Since then, clinical trials have expanded to offer groundbreaking opportunities for medical advancements. We’re here to run through the.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 17, 2024

The Union Ministry of Ayush (MoA) is taking steps to amend the Drugs and Cosmetics Act, 1940 to add the French Homoeopathic Pharmacopoeia and the European Pharmacopoeia under the standards on which the imports and manufacturing of homoeopathic drugs will be allowed in the country.

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Clinical Trial Podcast

JULY 31, 2022

Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients? To answer these questions and more, I invited Darshan Kulkarni to the show.

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The Pharma Data

JUNE 18, 2021

June 8, 2021 /PRNewswire/ — Allergan Aesthetics, an AbbVie company (NYSE: ABBV ), is changing the way BOTOX ® Cosmetic, the #1 selling neurotoxin treatment 1 , is connecting with consumers. “BOTOX ® Cosmetic is honoring and celebrating the dynamic people who use our products. IRVINE, Calif.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 13, 2023

Although provisions of the Pharmacy Practice Regulations (PPR) 2015 are not there in the Drugs and Cosmetics (D&C) Act 1940 but are framed under the Pharmacy Act 1948, the steps now being taken by the drugs control administration (DCA) in Tamil Nadu in a motive to strengthen the dispensing activities in pharmacies are completely agreeing […] (..)

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 6, 2023

The key issue is the lack of dedicated guidelines on the disposal under the Drugs & Cosmetics Act. There is a growing concern about the lack of stringent norms on disposal of unused and expired medicines that pose a threat to health and the environment.

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Cloudbyz

APRIL 12, 2022

Cloudbyz , makers of digital clinical research management solutions natively built and run on the Salesforce platform is headquartered in Naperville, Illinois. ClinChoice is committed to providing deep domain experience through reliable partnerships in support of clinical research trials around the world.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 19, 2023

Taking into account the four main components of regulator, industry, trade and patient/consumer in a medicine value supply chain, the Drugs and Cosmetics (D&C) Rules, 1945 and D&C Act, 1940 needs an urgent revamp as there is no clause of compensation for ADRs in patients, according to drug regulatory experts.

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XTalks

SEPTEMBER 14, 2022

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Many people choose to undergo non-invasive cosmetic procedures to prevent or reduce the appearance of signs of aging. Daxxify is effective, as safe as competitors, and has been well tolerated in clinical trials.

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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 6, 2022

The medical devices industry has urged the Centre to ensure obligation on the part of the buyer or users to purchase or use only those medical devices with required licenses and certifications under the New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, the draft of which has been circulated by the Union Health Ministry […].

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Cloudbyz

AUGUST 9, 2023

The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. This is where the platform approach comes into play.

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 21, 2022

Further, […].

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Pharmaceutical Technology

JUNE 10, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It’s nutraceutical segment offers rehydration, nutrition, vitamin supplements and cosmetics. The company operates branch offices, research facilities and factories in Japan.

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Pharmaceutical Technology

JUNE 10, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It’s nutraceutical segment offers rehydration, nutrition, vitamin supplements and cosmetics. The company operates branch offices, research facilities and factories in Japan.

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Olympian Clinical Research

NOVEMBER 30, 2023

Vitiligo, characterized by the loss of skin pigment and the formation of white patches, has been a subject of medical intrigue and research for decades. Understanding Vitiligo: More Than Skin Deep Vitiligo isn’t just a cosmetic concern; it’s a medical condition that can significantly impact an individual’s life.

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Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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Olympian Clinical Research

JUNE 2, 2021

Triggers can vary patient by patient, but some of the most common eczema triggers are: Cosmetic products. For patients who don’t find relief from over the counter or prescription medications, clinical trials are a great solution! Eczema Clinical Trials In Tampa & Largo. Detergents or soap. Food allergens.

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Delveinsight

FEBRUARY 22, 2021

opaque, contain zinc oxide or titanium dioxide, and may be cosmetically unacceptable to some patients. The rarity of the disease makes it difficult for researchers to study, and run clinical trials for its therapies. Betacarotene is used to improve light tolerance significantly.

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pharmaphorum

DECEMBER 15, 2022

We’re seeing everything from over-the-counter cold medication to cosmetic injection brands leverage different tiers of influencers. These DOLs can be anyone, from physicians, nurses, pharmacists, allied health professionals, and researchers to patients, caregivers, journalists, and science writers. Clinical trial recruitment.

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The Pharma Data

MAY 17, 2021

Conducting clinical trials to see if a drug is safe and effective can be a very time-consuming process. To meet the urgent demand for effective therapies, FDA has worked with clinical trial experts to rapidly advance best practices in the design and execution of clinical trials. Source link.

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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. For more on FDORA’s other provisions, see HPM’s complete summary here ).

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Advarra

SEPTEMBER 8, 2022

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations.

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Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. PK studies are conducted to confirm that dosimetry remains unchanged, and toxicology studies are needed to confirm that the therapeutic ratio and safety profile remain unchanged.

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FDA Law Blog

JANUARY 1, 2024

Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators. Patcos Cosmetics Pvt. Finally, FDA said in a Warning Letter that a Clinical Investigator, Anish S. Shah, M.D.,

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XTalks

JANUARY 12, 2021

The letter , which was sent on January 4, 2021, stated that several of the company’s products violated section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § Some examples include: “[A]ntiviral, ongoing clinical research on effectiveness against COVID-19”. “4-Thieves

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The Pharma Data

NOVEMBER 4, 2020

Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.

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Velocity Clinical Research

JUNE 29, 2023

With nearly three decades as a family physician and almost 25 years as a Principal Investigator (PI), Frank Eder, MD, believes two primary elements are critical for sustained success in clinical research. “You must have a true interest in the research side of it. But passion alone isn’t enough. and Canada.

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pharmaphorum

NOVEMBER 16, 2021

Largest tooth loss research study finds poor glycemic control in the over 30s results in fewer teeth. The collaborative research with Shiga University of Medical Science and Sunstar also proves that diabetes and smoking impact tooth retention. Key research results. About Diabetes and Oral Health research in Sunstar Group.

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Q: What is the major IND filing difference between investigator-initiated trials (IIT) and IND trials?

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The Pharma Data

DECEMBER 18, 2020

Director of the FDA’s Center for Biologics Evaluation and Research. effective in preventing COVID-19 disease among these clinical trial participants with 11 cases of COVID-19 in the vaccine group and 185 in the placebo group. study who did not have evidence of SARS-CoV-2 infection prior to the first dose of vaccine.

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FDA Law Blog

JUNE 2, 2024

This office was formed in 1994 to promote the inclusion of women in clinical trials and to provide leadership on topics related to the health of women. Vasisht, recently shared a statement, Protecting and Advancing the Health of Women Through Policy, Research, Education and Outreach , highlighting the work of the OWH.

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FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. Now there is a whole body of research that supports patients as partners in their own care, and the practice of medicine has largely corrected course.

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FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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Drug Discovery World

FEBRUARY 2, 2023

ends a federal mandate that experimental drugs need to be tested on animals before they can be used in human clinical trials 2. As simplified in a press release by the National Association for Biomedical Research (NABR), the act amends the Federal Food, Drug, and Cosmetic Act (21 U.S.C. The Modernization Act 2.0

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The Pharma Data

APRIL 26, 2022

director of the FDA’s Center for Drug Evaluation and Research. Given the similar course of COVID-19 disease in adults and pediatric patients, today’s approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults. Source link: [link].

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Pfizer

DECEMBER 13, 2022

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act, unless the authorization is terminated or revoked sooner. Research Vaccines. COVID-19 Research Vaccines. 12.09.2022. 11.23.2022.

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XTalks

MAY 22, 2023

It’s an extremely important factor I consider in my therapeutic process of restoring their natural beauty and appearance,” said Macrene Alexiades, MD, PhD, dual US-EU board-certified dermatologist, SkinVive by Juvéderm lead investigator and author of the clinical trial published in Dermatologic Surgery.

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