Pharmaceutical Technology

APRIL 24, 2023

While 80% of the world’s population practices some form of traditional medicine, according to the World Health Organization (WHO), the practice is regularly discredited due to a lack of scientific support and regulation as well as evidence of negative side effects with certain medicines.

Medicine 262

Medicine Drugs Production Research 262

Camargo

FEBRUARY 16, 2021

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Definition of a Rare Disease or Condition.

Production 130

Production Drugs Marketing In-Vitro 130

XTalks

SEPTEMBER 24, 2020

Despite our best efforts to avoid added chemicals, the food and beverages we consume likely contain one or more of some 10,000 chemicals allowed to be added to foods. Related: FDA Issues First Injunction of its Product Safety Rule.

Regulation 94

Regulation Hormones Containment Packaging 94

XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.

Vaccine 105

Vaccine Vaccination Production Manufacturing 105

World of DTC Marketing

OCTOBER 4, 2021

SUMMARY: The Facebook whistleblower lawsuit can be summed up in one sentence: Facebook prioritizes engagement above all else because it leads to more profits even if that engagement containing inflammatory information. Mt recommendation was no and was based on the amount of health misinformation I found on the site.

Branding 224

Branding Marketing Pharmacy Pharma Companies 224

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.

Development 242

Development Bioequivalency Generic Drugs Production 242

Pharmaceutical Technology

MAY 9, 2023

According to a June 2022 study, xylazine has been detected in the illicit drug supply in 36 US States, and the DEA has reported that approximately 30% of the fentanyl seized by the Agency contained xylazine. It makes sense to have a xylazine strip so you can check to see if your dope contains xylazine,” he says.

Drugs 278

Drugs Regulation Containment Scientist 278

STAT News

JANUARY 9, 2023

Cough medicine tainted with ethylene glycol that killed at least 19 children in Uzbekistan in late December 2022 has once again revealed lax oversight and regulation of pharmaceutical companies based in India. That preventable tragedy, which involves products made by Marion Biotech, based in Noida, India, echoes earlier cases.

Manufacturing 122

Manufacturing Containment Regulation Medicine 122

Scienmag

DECEMBER 10, 2021

Use of certain personal care products during pregnancy may impact maternal hormone levels, according to a new Rutgers study. Personal care and beauty products contain several ingredients that often include a wide range of endocrine-disrupting chemicals like phthalates, parabens, phenols, parabens and toxic metals.

Hormones 63

Hormones Production Containment Regulation 63

Pharmaceutical Technology

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.

Manufacturing 147

Manufacturing Production Containment Antibody 147

Pharmaceutical Technology

MAY 24, 2023

Allogeneic therapies begin with healthy donor samples to develop the eventual therapeutic product which can be administered to multiple patients. CGT trials operate with much lower volumes of manufactured final product. The labeling process of the final product is earlier than that for traditional trials.

Clinical Trials 246

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

Advarra

DECEMBER 17, 2024

These companies are laying the groundwork for more sophisticated AI applications designed to transform clinical operations, improving both efficiency and productivity. As AI continues to evolve, its ability to transform the efficiency, quality, and scalability of clinical research will grow exponentially.

Clinical Research 98

Clinical Research Research Trials Clinical Trials 98

Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies hold permission to market their products directly to consumers. Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers.

Marketing 130

Marketing Compliance Production Doctors 130

XTalks

AUGUST 12, 2024

Despite the elimination of many lead-based products in the US, certain goods, especially those imported, may still contain lead. Given that no safe level of lead exposure has been established, the FDA takes a proactive role in monitoring and regulating lead levels in food to protect public health.

Contamination 105

Contamination Compliance Regulation Production 105

STAT News

OCTOBER 19, 2022

After years of deliberation, the FDA recently announced a new set of rules it proposes to regulate claims on food packaging that a product is “healthy.” ” The most basic rule: the product must actually contain food, not just ingredients.

Packaging 98

Packaging Packaging Containment Regulation 98

Pharmaceutical Technology

JANUARY 24, 2023

The investigational adeno-associated virus (AAV) gene therapy candidate NGN-401 is claimed to be the first to deliver the full-length human MECP2 gene using the company’s Expression Attenuation via Construct Tuning (EXACT) gene regulation technology.

Gene Therapy 208

Gene Therapy Gene Gene Expression Regulation 208

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. The download contains detailed information on commercial pharmaceutical packaging contractors, and their product and service lines, alongside contact details to aid your hiring decision.

Packaging 100

Packaging Packaging Marketing Containment 100

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

Development 161

Development Production Immune Response Licensing 161

Camargo

NOVEMBER 15, 2021

It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements. In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”.

Development 187

Development Manufacturing Production Packaging 187

Pharmaceutical Technology

FEBRUARY 8, 2023

The recent town hall, titled “Clinical Development of Gene Therapy Products for Rare Diseases”, was meant to further that dialogue with those in pharmaceutical industry developing new gene therapies for underserved patient groups.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

FDA Law Blog

JULY 7, 2022

Specifically, FDASLA includes the Modernization of Cosmetics Regulation Act of 2022 proposing significant amendments to the FDC Act, intended to modernize safety standards for cosmetics in the United States. The bill includes certain exemptions for small businesses.

Cosmetics 52

Cosmetics Regulation Production Manufacturing 52

FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. The MoCRA rollout, though, does not preclude that FDA may practice some regulation by enforcement if it deems such action necessary.

Cosmetics 64

Cosmetics Production Compliance Regulation 64

XTalks

NOVEMBER 25, 2021

is recalling four lots of its injectable seizure medication levetiracetam over concerns of container closure integrity on vials of the drug product. Administration of a product that is not sterile may cause serious systemic infections that could pose to be life-threatening. Sagent Pharmaceuticals Inc.

Drugs 105

Drugs Packaging Packaging Containment 105

XTalks

JANUARY 31, 2023

The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. This update comes after a number of allegations claiming farmers have tried to sell non-organic or conventional food products with the lucrative white and green USDA “organic” label.

Regulation 52

Regulation Production Bacteria Packaging 52

Drug Patent Watch

JANUARY 14, 2025

The Thyroid Association’s Concerns The American Thyroid Association (ATA) had raised concerns about the FDA’s methods for determining bioequivalence between levothyroxine products[2]. They recommended avoiding switching between levothyroxine products, leading to a preference for brand-name prescriptions.

Generic Drugs 87

Generic Drugs Development Drugs Manufacturing 87

XTalks

OCTOBER 8, 2024

The 2024 Nobel Prize in Physiology or Medicine has been awarded to American scientists Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (or miRNA) and its role in post-transcriptional gene regulation. A gene contains instructions within our DNA.

Regulation 52

Regulation Genetics Scientist RNA 52

FDA Law Blog

FEBRUARY 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. Mullen — Sections of the radiological health regulations have been updated with the goal of lessening regulatory burdens. The regulations contain many requirements that are over 30 years old. 360ii, 360kk(a)(1), and 360nn(b))).

Radiology 52

Radiology Regulation Manufacturing Production 52

Camargo

JUNE 4, 2021

Heron Therapeutic received FDA approval for its bupivacaine/meloxicam extended-release solution product to treat post-operative pain after total knee replacement, bunionectomy, and groin hernia repair. Because of the significant public health need, FDA granted this 505(b)(2) pathway product a fast track designation in late 2017.

Development 130

Development Production Drugs Marketing 130

Advarra

OCTOBER 26, 2023

Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines.

Production 52

Production Containment Biohazard Biohazard 52

XTalks

OCTOBER 13, 2023

In the era of health-consciousness, sugar free cranberry juice is a product that consumers are eagerly looking for on the shelves. This diagnosis sparked a realization for the team, inspiring them to create beverages that were healthier and contained reduced sugar. Sugar is ubiquitous.

Containment 105

Containment Production Marketing Branding 105

World of DTC Marketing

MAY 24, 2022

Many claims may or may not accurately reflect what these products offer, “It’s the wild west.”. In another study of apps for anxiety, scientists found that out of the 25 highest-rated apps for fear, exactly zero contained any content consistent with evidence-based treatments. Does this mean we should give up?

Licensing 252

Licensing Licensing Scientist Production 252

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

Regulation 45

Regulation Production Cosmetics Sales 45

XTalks

DECEMBER 20, 2021

Last Friday, The Coca-Cola Company issued a recall of some of its beverages because the affected products may contain pieces of metal bolts, washers or other foreign objects. Both the Minute Maid and Coca-Cola beverages are set to expire in 2022, which means consumers might still have products that contain the unspecified contaminants.

Contamination 98

Contamination Containment Production Packaging 98

XTalks

JANUARY 17, 2023

Beginning this year, all food and dietary supplement manufacturers must clearly list sesame as an ingredient on product labels. We’re about to see a whole new book of regulations come into effect, with FDA labeling being one of the biggest ones,” said Bradley Saxe, President of Mainline Foods, in an interview with Xtalks last year.

Allergies 98

Allergies Packaging Packaging Containment 98

FDA Law Blog

JULY 11, 2023

Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme.

Protein 95

Protein Production Regulation Cosmetics 95

Pharmaceutical Technology

OCTOBER 28, 2022

According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

XTalks

JULY 26, 2021

Traditional meat production faces a wide array of safety concerns, from slaughterhouse sanitation to foodborne illnesses and much more. But just because plant-based meat production doesn’t involve slaughterhouses or mass production lines, doesn’t mean it is immune from safety concerns. FDA Regulation. Ultra-Processed.

Protein 98

Protein Contamination Allergies Bacteria 98