Medical Xpress

JANUARY 26, 2023

Bioengineered artificial skin has become an increasingly important and reliable platform for researchers to test the safety and efficacy of drugs and cosmetics. It can be produced on a large scale and is a good substitute for animal testing. The most promising technologies for production of in vitro models include 3D bioprinting.

Cosmetics 75

Cosmetics In-Vitro Drugs Production 75

FDA Law Blog

JULY 7, 2022

While FDASLA focuses on user fees and includes several other provisions regarding drugs and devices, it also includes provisions related to cosmetics. The current House bill does not include the cosmetic provisions and it remains to be seen which riders will survive and which will be eliminated.

Cosmetics 52

Cosmetics Regulation Production Manufacturing 52

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 […]

Pharmacy 134

Pharmacy Cosmetics Drugs Regulation 134

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.

Cosmetics 145

Cosmetics Manufacturing Drugs Clinical Trials 145

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 […].

Cosmetics 125

Cosmetics Licensing Licensing Drugs 125

Medical Xpress

APRIL 19, 2023

The skin is an appealing route for drug delivery because it allows drugs to go directly to the site where they're needed, which could be useful for wound healing, pain relief, or other medical and cosmetic applications.

Cosmetics 91

Cosmetics Drug Delivery Drugs 91

STAT News

MARCH 9, 2023

WASHINGTON — President Biden made lowering drug prices a key part of his budget with proposals to expand Medicare drug price negotiation, squeeze more rebates out of drug companies, and lower the cost of insulin for everyone with insurance. The request made Thursday also details a $7.2

Cosmetics 98

Cosmetics Drugs Insulin Regulation 98

BioTech 365

AUGUST 3, 2021

Eurofins Strengthens Its Global Leadership Position in Cosmetics and Personal Care Products Testing and Clinical Services and Grows Its Position in Dermatology Drug Testing Eurofins Strengthens Its Global Leadership Position in Cosmetics and Personal Care Products Testing and Clinical Services … Continue reading →

Cosmetics 52

Cosmetics Dermatology Production Drugs 52

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 […] (..)

Cosmetics 152

Cosmetics Pharmacy Regulation Drugs 152

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, (..)

Cosmetics 158

Cosmetics Manufacturing Drugs Clinical Trials 158

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.

Cosmetics 149

Cosmetics Regulation Medicine Drugs 149

World of DTC Marketing

JUNE 6, 2021

SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. Can diabetes patients really stay adherent to a drug for 63 weeks in which 85% of patients report GI side effects and will insurance cover the cost?

Drugs 318

Drugs Cosmetics Production FDA Approval 318

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.

Medicine 134

Medicine Cosmetics Drugs Clinical Trials 134

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. By reducing the movement of these muscles, wrinkles become less pronounced over time.

Botox 98

Botox FDA Approval Cosmetics Clinical Trials 98

Pharmaceutical Technology

SEPTEMBER 29, 2022

Holding a presence in the cosmetic dermatology sector, Curatio’s portfolio comprises more than over 50 brands that are commercialised in India. Curatio has built a commendable set of high market share brands in cosmetic and pediatric dermatology that we look forward to adding to our product offerings.”.

Dermatology 147

Dermatology Cosmetics Branding Scientist 147

FDA Law Blog

JANUARY 22, 2023

On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023 , Pub. FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. 117-328 (2022).

Cosmetics 59

Cosmetics Regulation Drugs Production 59

XTalks

MARCH 25, 2024

The latest phase of Oprah’s weight loss journey brought her to GLP-1 receptor agonist drugs, which have taken Hollywood and social media by storm. GLP-1 receptor agonists, a class of drugs initially developed to treat type 2 diabetes, have been found to have significant effects on weight loss.

Drugs 105

Drugs Medicine Life Science Cosmetics 105

Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen.

Drugs 52

Drugs Regulation FDA Approval Manufacturing 52

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 59

Cosmetics Compliance Generic Drugs Regulation 59

FDA Law Blog

AUGUST 10, 2023

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. Instead, FDA issued a request for records pursuant to Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA).

Manufacturing 52

Manufacturing Cosmetics Drugs Production 52

Roots Analysis

JANUARY 17, 2024

Renowned for psychiatric drugs such as Prozac, the company faced several challenges in revenue generation during the 2010s due to patent expiration of its innovative drugs. However, a strategic shift and a focus on innovative treatments have catapulted Eli Lilly to unprecedented heights, especially in the field of anti-obesity drugs.

Drugs 40

Drugs Cosmetics Marketing FDA Approval 40

Pharmaceutical Technology

MAY 16, 2023

It will benefit from Omega’s newly opened injectable manufacturing facility, which has received clearances from Health Canada and the US Food and Drug Administration, as well as from Juno’s commercial network and product development pipeline.

Cosmetics 130

Cosmetics Allergies Manufacturing Production 130

ProRelix Research

JUNE 26, 2023

As per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, […] The post US FDA Medical Device Applications appeared first on ProRelix Research.

Reagent 52

Reagent Cosmetics In-Vitro Drugs 52

XTalks

JANUARY 5, 2024

Eli Lilly launched LillyDirect this week, an online service that provides access to the company’s medicines, including its newly approved weight loss drug Zepbound (tirzepatide). Interestingly, the company’s blockbuster diabetes drug, Mounjaro (tirzepatide), is not available through the new digital service.

Drugs 59

Drugs Pharmacy Cosmetics Insulin 59

Pharma Tutor

FEBRUARY 2, 2023

FDA Inspections - Overview admin Thu, 02/02/2023 - 13:52 FDA Inspection is a regulatory process conducted by the United States Food and Drug Administration (FDA) to evaluate the compliance of food and drug establishments with FDA regulations and standards.

Cosmetics 52

Cosmetics Compliance Regulation Manufacturing 52

Pharmaceutical Technology

JUNE 10, 2023

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. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Pimitespib LoA Report. Buy the report here.

Cosmetics 100

Cosmetics Clinical Trials Clinical Trials Drugs 100

Pharmaceutical Technology

JUNE 10, 2023

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. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Pimitespib LoA Report. Buy the report here.

Cosmetics 100

Cosmetics Clinical Trials Clinical Trials Drugs 100

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.

Research 52

Research Cosmetics Clinical Trials Clinical Trials 52

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.

Contract Manufacturing 147

Contract Manufacturing Manufacturing Pharma Companies Cosmetics 147

Pharma in Brief

NOVEMBER 20, 2023

The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations. Natural health product vs. regulated drug In Winning Combination Inc.

Production 52

Production Cosmetics Regulation Branding 52

BioSpace

FEBRUARY 10, 2021

The cancer drugmaker pled guilty of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to investigators in federal court.

Cosmetics 69

Cosmetics Drugs 69

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.

Gene Editing 100

Gene Editing DNA Cosmetics Life Science 100

Pharmaceutical Technology

MARCH 1, 2023

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. GlobalData’s report assesses how Nedisertib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Gene Editing 100

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?

FDA Approval 52

FDA Approval Drugs Life Science Cosmetics 52

Pharmacy Checkers

FEBRUARY 12, 2021

With lies and deception, Big Pharma has used the threat posed by rogue websites and counterfeit drugs to push back against U.S. state legislation to gain access to lower drug prices in Canada. Simple summary: Canada’s brand drugs are priced much lower and states want access to them. There’s no gray in that statement.

Drugs 71

Drugs Pharmacy Licensing Licensing 71

XTalks

MARCH 13, 2024

As the stars lined up on Hollywood Boulevard for the Oscars on Sunday evening, Eli Lilly took the stage with a TV ad that took shots at Hollywood’s latest weight loss frenzy — GLP-1 drugs. This isn’t the first time the GLP-1 drugs made it to the Oscars.

Medicine 52

Medicine Cosmetics FDA Approval Drugs 52

FDA Law Blog

NOVEMBER 13, 2023

On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY. Director Deborah L.

Compliance 59

Compliance Drugs Cosmetics 59