Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. The regulator has issued a complete response letter. No concerns related to the clinical data package, safety or the medicine label.

Manufacturing 130

Manufacturing Drugs Hormones Packaging 130

Camargo

OCTOBER 20, 2021

While the potential for these effects may seem more obvious in the case of two chemically interacting drug molecules, the same is true with various device-device combinations. However, not every combination product can be classified so easily, and the OCP must follow certain work-flows and regulations to reach a decision.

Production 206

Production Regulation Drugs Development 206

XTalks

SEPTEMBER 24, 2020

Yet the US Food and Drug Administration (FDA), the agency charged with protecting our food from unsafe chemicals, hasn’t been doing the job Congress intended when it passed the 1958 Food Additives Amendment , according to a new citizen’s petition. Related: FDA Issues First Injunction of its Product Safety Rule.

Regulation 94

Regulation Hormones Containment Packaging 94

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. According to the recall announcement that was posted by the US Food and Drug Administration (FDA), Sagent says the issue affects reserve sample vials that could lead to a non-sterile product.

Drugs 105

Drugs Packaging Packaging Containment 105

Outsourcing Pharma

NOVEMBER 10, 2021

According to the market intelligence firm, automation appeals to drug packaging and manufacturing firms, thanks to their productivity-boosting potential.

Packaging 69

Packaging Packaging Pharma Packaging Manufacturing 69

World of DTC Marketing

AUGUST 7, 2022

The passage of the Inflation Control bill is an excellent first step in limiting high drug costs, but our healthcare system is still built for profit at the expense of patients. Once limited to a few new treatments, it’s now being applied widely, even to generic drugs and established regimens.?The Prior authorization is out of control.

Doctors 263

Doctors Doctor Generic Drugs Drugs 263

pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. How are regulated industries approaching the personalisation, or even hyper-personalisation, of content?

Regulation 97

Regulation Marketing Sales Branding 97

XTalks

JUNE 20, 2024

Also in this episode, Sydney talks about The US Food and Drug Administration’s (FDA) new requirement for prepackaged foods in the US. This rule would mandate front-of-package nutrition labeling, which would display key nutrient information on the front of the packaging, in addition to the existing nutrition label on the back.

Packaging 59

Packaging Packaging Protein Manufacturing 59

Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. For more insights on RWE, see the Camargo Blog and the FDA’s framework for RWE program.

Production 190

Production Trials Development Clinical Trials 190

Camargo

NOVEMBER 15, 2021

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). The FDA recently published the ICH’s Harmonised Guideline Q13, titled “ Continuous Manufacturing of Drug Substances and Drug Products.”

Development 187

Development Manufacturing Production Packaging 187

Pharma in Brief

DECEMBER 3, 2020

Any authorization for drugs, vaccines, and medical devices issued pursuant to the interim orders are also set to terminate when the respective interim order expires or is withdrawn. Drugs and Vaccines. Both interim orders are set to expire 1 year after they were issued, or sooner if withdrawn by the Minister.

Vaccine 98

Vaccine Vaccination Drugs Manufacturing 98

Camargo

JANUARY 12, 2022

As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. prior to filing an Investigational New Drug [IND] application).

Production 169

Production Gene Therapy Packaging Packaging 169

Pharmaceutical Technology

NOVEMBER 21, 2022

Six companies responded to the OPIR survey by claiming that a lower drug price was the main reason for them to change their strategy in the market while another two companies said that the drug price was the second most important factor for them to change their investment plan.

Marketing 173

Marketing Sales Manufacturing Drugs 173

Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Remember, only those questions listed in the package will be discussed during the INTERACT meeting.

Gene Therapy 155

Gene Therapy Gene Packaging Packaging 155

pharmaphorum

DECEMBER 10, 2021

Already scrambling to refile its obeticholic acid (OCA) drug for non-alcoholic steatohepatitis (NASH) after the FDA rejected it last year, Intercept Pharma was hoping for more luck in Europe, but has now withdrawn its EU marketing application. Shares in Intercept slipped around 15% after it announced the news.

Drugs 98

Drugs Sales Marketing Packaging 98

Roots Analysis

AUGUST 26, 2024

In today’s global landscape, sustainability has emerged as a pivotal concern across various sectors including the pharmaceutical packaging industry. What is Sustainable Packaging / Green Packaging? The following figure presents the raw materials used by the sustainable packaging companies.

Packaging 40

Packaging Packaging Production Manufacturing 40

Camargo

JULY 30, 2021

In 1981, I got my doctorate degree in Clinical Pharmacology, but more importantly, my research was heavily involved in neonatal medicine, developing drugs there. What would you say have been the most significant changes to pediatric drug development and clinical research in that time? I’ll give you an example.

Clinical Research 226

Clinical Research Research Gene Therapy Drugs 226

XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. So probably the biggest change for us on our packaging labels is we have to redo all that and add sesame.”.

Allergies 98

Allergies Packaging Packaging Containment 98

XTalks

JUNE 18, 2024

The US Food and Drug Administration (FDA) is preparing to introduce a new requirement for prepackaged foods in the US. This rule would mandate front-of-package nutrition labeling , which would display key nutrient information on the front of the packaging, in addition to the existing nutrition label on the back.

Packaging 40

Packaging Packaging Production Branding 40

FDA Law Blog

MARCH 6, 2022

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

Regulation 52

Regulation Compliance Manufacturing Packaging 52

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

Pharmaceutical Technology

MARCH 10, 2023

Freeze-drying systems companies help in the verification and validation monitoring of the freeze-drying process to comply with the latest regulations and good automated manufacturing practice (GAMP) guidelines. The process eliminates the disadvantages of conventional drying methods or freezing.

Manufacturing 147

Manufacturing Production Containment Antibody 147

XTalks

NOVEMBER 23, 2021

The expansion will include a new 30,000-square-foot building that will be able to produce 160 million doses of an mRNA vaccine per year, and up to 70 million prepared and packaged fill finish doses for commercial distribution annually. Additional production would be performed at other facilities for final packaging.

Manufacturing 98

Manufacturing Vaccine Vaccination Drugs 98

Pharmaceutical Technology

NOVEMBER 21, 2022

Six companies responded to the OPIR survey by claiming that a lower drug price was the main reason for them to change their strategy in the market while another two companies said that the drug price was the second most important factor for them to change their investment plan.

Marketing 130

Marketing Sales Manufacturing Drugs 130

Camargo

JUNE 4, 2021

May was a very active month for FDA guidance documents – here are some of the highlights: FDA Reauthorization Act Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs. When PREA was first instituted, the statutory requirements did not apply to products that received Orphan Drug Designation (ODD).

Development 130

Development Production Drugs Marketing 130

World of DTC Marketing

FEBRUARY 4, 2021

Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information. Amgen CEO Bob Bradway racked up a 2018 pay package of $18.6 prescriptions of finasteride, as the drug is known, for hair loss increased to over 2.4 ” Ouch. Annual U.S.

Vaccine 180

Vaccine Vaccination HR Packaging 180

Pharmaceutical Technology

AUGUST 30, 2022

Oswaldo Cruz Foundation will package the drug in its facility in Rio de Janeiro before supplying it to the Brazilian public health system; the company is also involved in clinical trials for the drug’s possible use as Covid-19 prophylaxis. Eurofarma will obtain the drug product from facilities in the US.

Manufacturing 195

Manufacturing Marketing Pharma Companies Vaccine 195

FDA Law Blog

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package. million).

Drugs 52

Drugs Containment Packaging Packaging 52

XTalks

JULY 27, 2022

Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal. Several other customers said they received leaking bottles of rotten-smelling sauce in the mail, with approximately 50 packages being impacted.

FDA Approval 98

FDA Approval Packaging Packaging Production 98

XTalks

SEPTEMBER 17, 2020

The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. an Illinois-based processor of sprouts and soy products.

Production 98

Production Contamination Cosmetics Bacteria 98

Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

Manufacturing 130

Manufacturing Sales Packaging Packaging 130

Camargo

JANUARY 19, 2021

On the other hand, an NDA for a drug improvement product utilizing the 505(b)(2) pathway typically has a Phase 1 bridging study, for which the drug product and API generally need to be at the to-be-manufactured stage. CMOs are subject to cGMP regulations, so they have standard operating procedures they must follow.

Production 135

Production Branding Manufacturing Contract Manufacturing 135

FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. Hyman, Phelps & McNamara, P.C. (“HP&M”)

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

FDA Law Blog

JANUARY 3, 2024

Responsible for “Protecting Human and Animal Health,” CVM makes sure that the drugs, devices, and food we provide for our pets are safe and effective. CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA).

Drugs 59

Drugs Production Containment Licensing 59

FDA Law Blog

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price. See 42 U.S.C.

Drugs 59

Drugs Manufacturing Regulation Production 59

XTalks

JULY 26, 2024

Plastics are ubiquitous in consumer and industrial products, ranging from packaging to automotive parts. Despite concerns, current evidence does not show significant migration of these particles from plastic food packaging into foods and beverages. Understanding their presence and potential impacts is crucial for industry stakeholders.

Contamination 52

Contamination Regulation Packaging Packaging 52

pharmaphorum

OCTOBER 12, 2022

The 2023 Transdermal and Microneedle Drug Delivery Conference will explore real world applications of microneedles in drug delivery and strategies for advanced and user-centric device design. Regulation of transdermal delivery systems will be another key theme addressed, in combination with clinical trial optimization.

Drug Delivery 40

Drug Delivery Drugs Packaging Packaging 40