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

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 142

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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Cosmetics Licensing Licensing Drugs 131

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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Cosmetics Pharmacy Regulation Drugs 161

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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Cosmetics Regulation Medicine Drugs 158

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 21, 2022

The Karnataka drugs control department is insisting that all the cough syrup manufacturers dealing in ethylene glycol and diethylene glycol will now need to procure solvents like glycerin and propylene glycol complying to pharmacopeia standards directly from manufacturers as required under para 10 of the Schedule M of the Drugs & Cosmetics Act, (..)

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Cosmetics Manufacturing Drugs Clinical Trials 167

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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Medicine Cosmetics Drugs Clinical Trials 141

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

MAY 24, 2023

This is where unified clinical trial management solutions come into the picture, enhancing efficiency, reducing time to market, and ensuring high-quality, scientifically validated consumer products. A delay in trials or approval can significantly impact the product’s success and the company’s bottom line.

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Clinical Trials Clinical Trials Production Trials 52

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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Research Cosmetics Clinical Trials Clinical Trials 52

Pharmaceutical Technology

JUNE 10, 2023

Pimitespib is under clinical development by Otsuka Pharmaceutical and currently in Phase I for Metastatic Lung Cancer. According to GlobalData, Phase I drugs for Metastatic Lung Cancer does not have sufficient historical data to build an indication benchmark PTSR for Phase I. Buy the report here.

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Cosmetics Clinical Trials Clinical Trials Drugs 100

Pharmaceutical Technology

JUNE 10, 2023

Pimitespib is under clinical development by Otsuka Pharmaceutical and currently in Phase I for Metastatic Lung Cancer. According to GlobalData, Phase I drugs for Metastatic Lung Cancer does not have sufficient historical data to build an indication benchmark PTSR for Phase I. Buy the report here.

Cosmetics 100

Cosmetics Clinical Trials Clinical Trials Drugs 100

Drug Discovery World

NOVEMBER 30, 2023

The Food and Drug Administration (FDA) said it will investigate the safety of BCMA- or CD19-directed autologous CAR-T cell immunotherapies, following reports of T cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in these patients.

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Cosmetics Clinical Trials Clinical Trials Gene Therapy 65

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. Recall powers for all drugs: The budget reveals legislative as well as spending plans; the agency wants to expand its authority to recall any drug.

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Contract Manufacturing Manufacturing Pharma Companies Cosmetics 147

Pharmaceutical Technology

MARCH 1, 2023

According to GlobalData, Phase I drugs for Neuroendocrine Tumors have a 74% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Nedisertib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Gene Editing DNA Cosmetics Life Science 100

Pharmaceutical Technology

MARCH 1, 2023

Nedisertib is under clinical development by Merck and currently in Phase I for Head And Neck Cancer Squamous Cell Carcinoma. According to GlobalData, Phase I drugs for Head And Neck Cancer Squamous Cell Carcinoma have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. Buy the report here.

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Gene Editing DNA Cosmetics Life Science 100

XTalks

JANUARY 25, 2023

Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. The drug is taken once a day in conjunction with diet and exercise. What is the Animal Drug Regulatory Process?

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FDA Approval Drugs Life Science Cosmetics 52

FDA Law Blog

JANUARY 2, 2023

Comprehend the structure of FDA and the roles of the three major agency centers: CDER, CBER and CDHR, master the basics of the application and approval processes for drugs and biologics, gain a practical working knowledge of clinical trial process for pharmaceutical products and much more!

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Clinical Trials Clinical Trials Drugs Production 59

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.

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Clinical Trials Clinical Trials Cosmetics Trials 52

FDA Law Blog

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For many drugs, both a registry and an outcomes study are required.

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Marketing Drugs Regulation Cosmetics 59

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 U.S.C. §

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Clinical Trials Clinical Trials Trials Regulation 52

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. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022.

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Manufacturing Production Drugs FDA Compliance 59

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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Clinical Trials Clinical Trials In-Vivo In-Vitro 64

Cloudbyz

AUGUST 9, 2023

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. Let’s delve into why this method is paramount for the transformation of clinical research management.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

JUNE 17, 2022

Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness. The drug was evaluated in 1,200 adult patients with severe AA.

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FDA Approval Gene Expression Cosmetics Trials 97

pharmaphorum

DECEMBER 15, 2022

We’re seeing everything from over-the-counter cold medication to cosmetic injection brands leverage different tiers of influencers. Back in 2015, the influencer-of-influencers, Kim Kardashian, was slammed for failing to mention the potential side effects of an anti-nausea drug, leading to the US FDA getting involved.

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Clinical Trials Clinical Trials Life Science Marketing 103

FDA Law Blog

MAY 3, 2021

Butler — 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 U.S.C. §

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Clinical Trials Clinical Trials Trials Regulation 40

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account. Regulatory Considerations for Biologics.

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Development Production Immune Response Licensing 161

FDA Law Blog

AUGUST 4, 2023

A drug or hormonal substance, other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone not listed in 21 C.F.R. In addition, DASCA gave DEA authority to issue a permanent order adding a drug or substance to the definition of “anabolic steroid” if it satisfies the criteria for being considered an anabolic steroid.

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Hormones Manufacturing Regulation Drugs 52

The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age.

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Vaccination Vaccine Clinical Trials Clinical Trials 40

XTalks

JANUARY 12, 2021

The US Food and Drug Administration (FDA) has sent a warning letter to Coco’s Holistic Specialties & Apothecary , an online holistic and Eastern medicine company, for falsely advertising its products’ ability to prevent, treat, cure and even diagnose people with COVID-19. 352 for false or misleading labeling.

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Production Cosmetics Sales Drugs 93

pharmaphorum

SEPTEMBER 29, 2022

Food and Drug Administration (FDA) regulation as a medical device. Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code.

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Development Regulation Production Life Science 104

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. Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11.

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Compliance Regulation Packaging Packaging 52

FDA Law Blog

AUGUST 16, 2021

Koblitz — Meet the newest category of drug applications: the PANDA. While generic drugs as we know them are a creation of the 1984 Hatch-Waxman Amendments, the Federal Register Notice explains that FDA first introduced the concept of an ANDA in 1968 to facilitate approval of Drug Efficacy Study Implementation (DESI) drugs.

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Production Drugs Generic Drugs Cosmetics 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. That did not happen.

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Production Drugs FDA Approval Compliance 59

FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” So, we crafted the Patient-Focused Drug Development, or PFDD, a commitment that was agreed to in PDUFA V. The data supports patients and caregivers having the choice to use this drug. By James E.

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FDA Approval Drugs Development Clinical Trials 52

Advarra

JULY 19, 2022

If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application. Q: Please discuss the transfer of investigational new drug (IND) sponsorship from one sponsor to another and that process. The sponsor is the pharmaceutical company conducting the trial.

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Packaging Packaging Drugs Containment 52