Bio Pharma Dive

MARCH 10, 2021

and European regulators in hopes of resuming study of the treatment as well as sales of a related product. The biotech is discussing its findings with U.S.

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Gene Therapy Gene Sales Regulation 290

NPR Health - Shots

JULY 30, 2022

Delta-8 is a hemp product designed to get users high, but misleading labels or added chemicals have caused people to get sick. And a lack of federal regulation or guidance has states stepping in.

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Regulation Sales Production 144

Drug Patent Watch

JANUARY 29, 2025

As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. Generic drug production involves replicating a brand-name medication's active ingredient, formulation, and dosage. The quality and purity of these ingredients can greatly impact the final product's efficacy and safety.

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Generic Drugs Production Compliance Drugs 78

Bio Pharma Dive

JULY 5, 2023

The vaccine has a chance to become Moderna’s second approved product and could help offset declining sales for its COVID-19 shot.

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Vaccination Vaccine Regulation Sales 189

Worldwide Clinical Trials

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. The process, from patient coordination through manufacturing and administration, is intricate, time-sensitive, and highly regulated.

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Camargo

OCTOBER 15, 2020

If a single-arm trial was conducted as the pivotal trial for regulatory approval of those existing products, the sponsor will certainly want to do the same. To approve a product, the FDA requires substantial evidence of effectiveness, consisting of adequate and well-controlled (A&WC) trials. Simply, BIAS.

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Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things.

Clinical Trials 147

Clinical Trials Clinical Trials Regulation Trials 147

pharmaphorum

JUNE 10, 2022

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency.

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Regulation Production Life Science Drugs 133

pharmaphorum

OCTOBER 11, 2022

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy? ” The post Wellcome funds work on regulating digital mental health tools appeared first on. . The healthcare charity is providing £1.8

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STAT News

JANUARY 26, 2023

WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too. Read the rest…

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Regulation Pharmacy Production Drugs 124

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 21, 2023

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

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Regulation Drugs Licensing Licensing 188

Bio Pharma Dive

JULY 10, 2024

Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.

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Drugs Regulation Production Marketing 204

XTalks

JULY 30, 2024

The US Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) declared Salmonella an adulterant in raw breaded stuffed chicken products when contamination levels exceed one colony-forming unit (CFU) per gram. This approach emphasizes stringent testing and preventive measures at earlier stages of the supply chain.

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Regulation Contamination Production Manufacturing 98

Camargo

OCTOBER 20, 2021

As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents. Such products require more complex target profiling. Such products require more complex target profiling. Definition of Combination Products.

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Production Regulation Drugs Development 206

Pharma Mirror

MARCH 29, 2022

This newly launched liquid filling machine is the pharmaceutical machinery manufacturer’s answer to the growing demand for ophthalmic products with no added preservatives. Much stricter GMP regulations apply when these modern pharmaceutical formulations have to be filled under sterile conditions, and the Oftalmica.

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Production Regulation Development 130

Pharmaceutical Technology

SEPTEMBER 8, 2022

Good Therapeutics focuses on the development of PD-1-regulated IL-2 drugs that are based on innovative conditionally active drug technology. With the takeover, Roche will attain rights to a conditionally active, PD-1-regulated IL-2 programme of Good Therapeutics.

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Regulation Development Manufacturing Drugs 278

Pharmaceutical Technology

NOVEMBER 22, 2024

The UK’s proposed regulations would provide the legal framework for POC manufacturing of cell therapies, including quality assurance.

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Production Regulation Manufacturing 130

Pharmaceutical Technology

JUNE 20, 2023

SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Last month, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted marketing authorisation for SKYCovione to prevent Covid-19 resulting from SARS-CoV-2 infection in people aged 18 years and above.

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Vaccination Vaccine Protein Clinical Trials 363

Bio Pharma Dive

DECEMBER 21, 2020

The regulator declined to approve inclisiran, which Novartis acquired in its buyout of The Medicines Co., after agency staff weren't able to inspect a production facility in Europe.

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Regulation Medicine Production 195

Rethinking Clinical Trials

FEBRUARY 7, 2024

Food and Drug Administration (FDA) Commissioner Robert Califf asked the Reagan-Udall Foundation to conduct research and consult with experts to better understand how consumers find, consume, and perceive health information, especially regarding FDA-regulated products. Winckler, RPh, Esq) appeared first on Rethinking Clinical Trials.

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Regulation Production Clinical Trials Clinical Trials 120

FDA Law Blog

DECEMBER 22, 2022

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. This provision represents a complete shift in the way FDA is allowed to regulate products.

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Regulation Medicine Doctor Doctors 114

NPR Health - Shots

NOVEMBER 29, 2022

The FDA seems poised to at last yank some products aimed at teens from the market. The advent of vaping revived nicotine addiction among young people after a dramatic decline. Will it work? Image credit: Helen H. Richardson/Denver Post via Getty Images)

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Regulation Production Marketing 134

Pharma Mirror

FEBRUARY 6, 2024

In addition to utilizing RWE in clinical research, there is a growing trend toward implementing RWE early in the product development lifecycle. In recent years, European regulators have supported the The post RWE’s Impact on Product Lifecycle for Biopharma Startups appeared first on Pharma Mirror Magazine.

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Production Packaging Packaging Clinical Research 100

CTTI (Clinical Trials Transformation Initiative)

OCTOBER 17, 2024

They discussed the value of disease progression modeling an d identified key areas that need to be addressed to incorporate DPM approaches more effectively in medical product development and regulatory decision-making.

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Clinical Trials Clinical Trials Trials Production 81

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 12, 2022

The […].

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Regulation Manufacturing Production Marketing 189

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

Trials 189

Trials Clinical Trials Clinical Trials Drugs 189

Camargo

SEPTEMBER 8, 2021

On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. For some time, the FDA has asserted its authority to decide on the classification of a product which met the definition of both a drug and a device.

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Development Regulation Production Drugs 186

World of DTC Marketing

JULY 8, 2021

Some of the TV spots for drugs are horrible, and some products should even be on TV because of terrible fair balance. One consistent learning from ALL the research I have been involved in is that patients pick up when death is listed as a side effect and stay far away from the product.

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Contamination Production Marketing Drugs 297

Drug Patent Watch

DECEMBER 9, 2024

This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. The emphasis on analytical and functional testing through sophisticated technology is crucial in overcoming these challenges.

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Clinical Trials Clinical Trials Immune Response Production 97

Pharmaceutical Technology

NOVEMBER 28, 2022

on meeting clinical development and commercial milestones in the future, in addition to tiered royalty payments, upon the marketing of the product. A key natural regulator, NRF2 controls antioxidant genes’ expression. It is crucial in cellular defence against external insults and inflammatory response regulation. .

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Camargo

SEPTEMBER 2, 2020

Sponsors and regulators use surrogate endpoints to predict the long-term benefits of drug products that. The post Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020 appeared first on Camargo.

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Regulation Production Drugs 163

Bio Pharma Dive

OCTOBER 6, 2023

Regulators’ holdup of the deal had stoked investor fears of greater scrutiny on M&A. In the end, Amgen agreed to requirements meant to guard against product “bundling.”

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Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. They can assist with analytical method development and validation, stability testing, and characterization of drug substances and products.

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Compliance Manufacturing Production Regulation 98

Pharma Times

MAY 10, 2024

The sandbox will help to inform future AI Airlock projects and influence future AlaMD guidance

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Regulation Production Medicine 122

NPR Health - Shots

NOVEMBER 28, 2022

The bottom base of some Green Sprouts products can break off, exposing a solder dot that contains the toxic metal, a federal regulator said. Consumer Product Safety Commission) No injuries have been reported from such incidents. Image credit: U.S.

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Containment Regulation Production 145

Pharmaceutical Technology

SEPTEMBER 4, 2024

Despite the best efforts of pharmaceutical manufacturers and regulators to improve the security and traceability of drug products, counterfeits continue…

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Regulation Manufacturing Production Drugs 130

Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

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