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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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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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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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 16, 2023

The Drug Controller General of India (DCGI) has issued a show cause notice to online pharmacies including Tata 1mg for allegedly stocking and selling drugs in contravention of the provisions of the Drugs and Cosmetics Act, 1940 and Rules, once again bringing back the long pending issue of lack of regulations on e-pharmacies under the […]

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Pharmacy Cosmetics Drugs Regulation 138

Cloudbyz

OCTOBER 19, 2023

Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount. In recent years, the need for a unified clinical trial management platform has become increasingly evident. Cost Efficiency: Centralized data management reduces administrative overhead, minimizing trial costs.

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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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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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Botox FDA Approval Cosmetics Clinical Trials 98

Cloudbyz

FEBRUARY 29, 2024

AI-enabled data extraction holds immense promise in expediting case processing within clinical trials, offering a transformative approach to streamline workflows and enhance efficiency. In this blog, we delve into the potential of AI in pharmacovigilance and its implications for clinical trial safety monitoring.

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Clinical Trials Clinical Trials Trials Compliance 59

Cloudbyz

MAY 24, 2023

The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis. Consumer product clinical trials typically involve the evaluation of new formulations or ingredients for safety, efficacy, and user acceptability.

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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.

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 21, 2022

Further, […].

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Cloudbyz

APRIL 12, 2022

The company helps life sciences, medical devices and clinical research organizations (CRO) meet their clinical research management goals by connecting all relevant processes across the clinical trials processes and, externally with its external stakeholders. Follow us on: LinkedIn | Facebook | Twitter.

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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? Should a Sponsor get access to patient data collected outside a clinical trial setting?

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Drug Discovery World

NOVEMBER 30, 2023

The reports were received from clinical trials and postmarketing adverse event (AE) data sources. The FDA has cautioned that patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies.

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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. Pimitespib overview Pimitespib (Jeselhy) belongs to a class of antineoplastic drugs.

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Cosmetics Clinical Trials Clinical Trials Drugs 100

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. Pimitespib overview Pimitespib (Jeselhy) belongs to a class of antineoplastic drugs.

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Cosmetics Clinical Trials Clinical Trials Drugs 100

World of DTC Marketing

JUNE 6, 2021

Still study trials show Wegovy is more effective than any other weight loss management drug currently on the market. Nearly 85% of trial participants reported adverse events, more than 70% affecting the gastrointestinal tract. Some of the more common side effects include: Nausea Vomiting Diarrhea.

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Pharmaceutical Technology

MARCH 30, 2023

The FDA’s proposed FY2024 Budget tops $7bn, to be shared between drug, food, and cosmetics tasks and overheads such as buildings; this is $372m higher than in FY 2023, a 10% increase. Device shortages and supply chain: +$11.6m, for a total of $21.6m, for the Resilient Supply Chain and Shortages Program for medical devices.

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Pharmaceutical Technology

MARCH 1, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Gene Editing DNA Cosmetics Life Science 100

Pharmaceutical Technology

MARCH 1, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Gene Editing DNA Cosmetics Life Science 100

Pharmaceutical Technology

APRIL 4, 2023

On April 4, Scorpion Therapeutics announced a collaboration and license agreement with the French dermo-cosmetic and pharmaceutical group Pierre Fabre to codevelop two next-generation epidermal growth factor receptor (EGFR) inhibitors. STX-241 and STX-721, both target EGFR mutations in non-small cell lung cancer (NSCLC).

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XTalks

JUNE 17, 2022

Treatments for AA have been limited and largely cosmetic, such as the use of wigs and false eyelashes, or corticosteroid injections in the scalp. Alopecia gained considerable attention after Will Smith’s infamous incident at the Oscars that brough attention to his wife Jada Pinkett Smith’s struggles with the condition.

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FDA Approval Gene Expression Cosmetics Trials 97

FDA Law Blog

NOVEMBER 15, 2022

At DOJ, Mr. Claud prosecuted and supervised complex criminal and civil trial litigation and investigations under the Food, Drug, and Cosmetic Act, Federal Trade Commission Act, Consumer Product Safety Act, and Federal data privacy laws.

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Compliance Cosmetics Regulation Pharmacy 52

Cloudbyz

AUGUST 9, 2023

Unified Data Management Clinical trials generate vast amounts of data, from patient records to lab results and monitoring findings. With everything in one place, researchers can obtain a holistic view of the trial, which is vital for making informed decisions. This is where the platform approach comes into play.

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Clinical Research Research Clinical Trials Clinical Trials 52

pharmaphorum

JULY 16, 2021

Mesdopetam is currently in a phase 2b trial as a potential treatment option for people living with Parkinson’s who have uncontrolled involuntary movements (dyskinesias) caused by treatment with levodopa, the standard therapy for the disorder. Ipsen’s other main research areas are oncology and rare diseases.

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Licensing Licensing Cosmetics Drugs 89

Olympian Clinical Research

NOVEMBER 30, 2023

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. Participate in Pioneering Research We invite individuals affected by vitiligo to participate in our ongoing clinical trials.

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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. Content current as of: 05/17/2021.

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Clinical Trials Clinical Trials Cosmetics Trials 52

The Pharma Data

JANUARY 6, 2021

Rare Vaccination Side Effect in People Who Received Cosmetic Facial Fillers. Food and Drug Administration (FDA) noted that there have been a few reports of people who received cosmetic injections to smooth wrinkles or plump lips having unexpected swelling related to the COVID-19 vaccination. Here’s a look. An update from the U.S.

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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. Dust mites and other allergens.

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Clinical Trials Clinical Trials Clinical Research Trials 52

FDA Law Blog

MAY 3, 2021

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 C.F.R. §§ 11.10, 11.44(a).

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Clinical Trials Clinical Trials Trials Regulation 52

pharmaphorum

DECEMBER 15, 2022

We’re seeing everything from over-the-counter cold medication to cosmetic injection brands leverage different tiers of influencers. Clinical trial recruitment. Social media can be a powerful tool for improving clinical trial recruitment, a process that has traditionally been notoriously ineffective.

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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

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. 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.

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The Pharma Data

NOVEMBER 30, 2020

We are pleased with the outcome of the Pre-IND meeting and look forward to preparing the IND filing and commencing our pivotal registration trial in 2021,” said Robert Dempsey, Chief Executive Officer, TearClear. ” About the 505(b)(2) Pathway. . ” About the 505(b)(2) Pathway. Section 505(b)(2) of the U.S.

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The Pharma Data

FEBRUARY 13, 2022

As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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