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

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

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container closure systems are highly regulated by health agencies. They provide specific guidance on packaging requirements for closed closure integrity (CCI) and general integrity testing.

Packaging 98

Packaging Packaging Containment Production 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. However, that will depend on how quickly Lilly can address the regulator’s manufacturing concerns.

Manufacturing 130

Manufacturing Sales Packaging Packaging 130

XTalks

OCTOBER 7, 2022

As awareness grows around the world about the problem of food waste, one culprit is being scrutinized: best before dates on food packaging. While food and beverage manufacturers have used the labels for decades to estimate peak freshness, consumers are confused about date codes, often causing more food waste than necessary.

Packaging 97

Packaging Packaging Manufacturing Production 97

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Manufacturing Controls. Food and Drug Regulations , C.R.C., Medical Devices Regulations , SOR/98-282. Risk Management Plan (RMP).

Regulation 98

Regulation Drugs Manufacturing Production 98

Outsourcing Pharma

NOVEMBER 10, 2021

Wasdell, a UK-based packaging and manufacturing provider in the UK, has opened a quality control laboratory in Dundalk to analyze products for its pharmaceutical clientele.

Packaging 52

Packaging Packaging Manufacturing Production 52

pharmaphorum

AUGUST 12, 2022

Embracing Continuous Manufacturing. Continuous manufacturing could be the solution. Unlike batch manufacturing, where drug production is segmented into a series of slow-moving steps, continuous manufacturing relies on a fully integrated process that runs uninterrupted from beginning to end.

Manufacturing 57

Manufacturing Production Drugs Regulation 57

XTalks

NOVEMBER 23, 2021

Canadian pharma and biotech contract development and manufacturing organization (CDMO) Biovectra has announced plans for building one of the first state-of-the-art mRNA vaccine and biomanufacturing facilities in Canada. Additional production would be performed at other facilities for final packaging. million, respectively.

Manufacturing 98

Manufacturing Vaccination Vaccine Drugs 98

XTalks

MARCH 23, 2022

Since consumers are more health-conscious than ever, some food manufacturers are pulling out all the stops to convince people to purchase highly processed and unhealthy products with misleading food labeling. . Respondents cited packaging as the top area brands should focus on if they want to increase purchase intent.

Manufacturing 119

Manufacturing Production Branding Packaging 119

XTalks

MAY 18, 2023

Cornell University researchers have been making strides in the development of a revolutionary tool to combat dangerous pathogens in commercial dry food manufacturing plants. Food manufacturers use steam for tasks like dehydration, distillation, pasteurization and cooking, which helps preserve the taste and texture of their offerings.

Manufacturing 52

Manufacturing Contamination Production Packaging 52

XTalks

OCTOBER 12, 2022

Once every two years, food manufacturers must undergo the US Food and Drug Administration (FDA) registration renewal process to ensure and uphold food safety. Agents, owners or operators of food manufacturing facilities must go through the FDA registration renewal process before the deadline. If not, the registration will be rejected.

Manufacturing 52

Manufacturing Packaging Packaging Compliance 52

XTalks

SEPTEMBER 24, 2020

In terms of the potential harms of food additives and packaging, synthetic chemicals that affect hormones have additive or synergistic effects. Related: FDA Issues First Injunction of its Product Safety Rule. An increasing number of studies suggest some food additives can interfere with a child’s hormones, growth, and development.

Regulation 94

Regulation Hormones Containment Packaging 94

Pharmaceutical Technology

MARCH 10, 2023

The list also includes manufacturers and suppliers of biological safety cabinets, clean benches, nanotechnology enclosures, drying chambers, vacuum pumps, filters, remote blowers and exhausters, loading and unloading systems as well as controlling and monitoring systems.

Manufacturing 147

Manufacturing Production Containment Antibody 147

FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.

Generic Drugs 45

Generic Drugs Manufacturing Drugs Cosmetics 45

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. Beginning this year, all food and dietary supplement manufacturers must clearly list sesame as an ingredient on product labels.

Allergies 98

Allergies Packaging Packaging Containment 98

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 provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

XTalks

AUGUST 25, 2023

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). These certifications are often sought by food manufacturers to assure consumers about the safety of their products for those with food allergies, intolerances and special dietary requirements.

Allergies 98

Allergies Manufacturing Contamination Production 98

Camargo

NOVEMBER 15, 2021

FDA Publishes ICH Guidelines on Continuous Manufacturing. The FDA recently published the ICH’s Harmonised Guideline Q13, titled “ Continuous Manufacturing of Drug Substances and Drug Products.” Batch steps include filter drying, milling, and packaging.

Development 187

Development Manufacturing Production Packaging 187

Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

Marketing 173

Marketing Sales Manufacturing Drugs 173

Pharma Packaging Solutions

DECEMBER 17, 2020

During my thirty fours years in the packaging business, I have realized packaging touches more departments than any other component purchased by our customers. The marketing department is always engaged considering the package is the first impression impacting the customer. – Scott Garverick.

Packaging 52

Packaging Packaging Contract Packaging Manufacturing 52

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. These distinctions are important as they determine the regulatory burden required to market a product in Canada.

Production 52

Production Cosmetics Regulation Branding 52

The Pharma Data

OCTOBER 26, 2020

Under the terms of the agreement, Novasep will be in charge of developing and manufacturing (cell culture, AAV expression, purification, aseptic distribution and quality control) the two AAV vectors designed for the Sensorion OTOF-GT project and will supply Drug Product batches to support preclinical and clinical studies. About Sensorion.

Gene Therapy 52

Gene Therapy Gene Manufacturing Production 52

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

FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

Manufacturing 59

Manufacturing Packaging Packaging Production 59

Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

Marketing 130

Marketing Sales Manufacturing Drugs 130

XTalks

APRIL 14, 2022

Laura has more than 30 years of experience implementing food safety and quality control programs for packaging, processing, retail operations and food service. Laura has worked with global manufacturers and retailers in the implementation of their workplace and food safety programs.

Manufacturing 98

Manufacturing Regulation Packaging Packaging 98

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

pharmaphorum

AUGUST 20, 2020

BioMarin previously agreed with the FDA on a data package necessary to support approval, but the company said the regulator has introduced a new recommendation for two years of safety and efficacy data. This data could be generated by the ongoing phase 3 GENEr8-1 trial which uses annualised bleeding rate as a primary endpoint.

Gene Therapy 56

Gene Therapy Drugs Regulation Gene 56

FDA Law Blog

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” See, e.g., 42 CFR § 430.0.

Genome 102

Genome Genomics Manufacturing Production 102

Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. In 1997, FDA released regulations providing guidance on the use of electronic systems. Un-specified identified Agency regulations. There are many factors in how Part 11 regulations affect software.

Compliance 52

Compliance Regulation Packaging Packaging 52

FDA Law Blog

MARCH 28, 2022

Circuit held that products that simultaneously meet both the FD&C Act’s general “drug” definition and its more-restrictive “device” definition must be classified and regulated as “devices,” FDA issued an “ Immediately in Effect Guidance ” to implement the decision as applied to ophthalmic products.

Regulation 40

Regulation Production Compliance Manufacturing 40

XTalks

SEPTEMBER 17, 2020

Related: FDA Announces Slow Phase-Out of Certain PFAS Chemicals Used in Food Packaging. FDA Chief Counsel Stacy Amin said in a statement , “Manufacturing foods in violation of the Produce Safety Rule and Current Good Manufacturing Practice regulations places consumers’ health at risk.

Production 98

Production Contamination Cosmetics Bacteria 98

XTalks

APRIL 11, 2024

As a staple spice in many kitchens, the discovery of elevated lead levels in cinnamon products has prompted a closer look at food safety practices and regulations. Additionally, the processing of cinnamon, including drying, grinding and packaging, can introduce lead if the equipment or materials are contaminated.

Contamination 59

Contamination Branding Production Containment 59

FDA Law Blog

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

Drugs 59

Drugs Licensing Licensing Production 59

Camargo

JANUARY 12, 2022

INTERACT meeting discussions may focus on topics such as the design of IND-enabling toxicity studies, complex manufacturing technologies or processes, and the development of innovative devices to be used with drug or biologic products. Receipt of Background Package. Response Time. calendar days). At the time of the meeting request.

Production 169

Production Gene Therapy Packaging Packaging 169

Drug Discovery World

FEBRUARY 27, 2024

The epigenome is a system of reversible marks that regulate how the DNA is read, translated, and used. The epigenetic system can selectively package regions of the DNA away, making them inaccessible and, therefore, less active. For both allogeneic and autologous treatments, CAR manufacturing can be labour-intensive and highly variable.

Gene Expression 59

Gene Expression DNA Genetics Gene 59