Cloudbyz

MAY 24, 2023

Consumer products companies constantly strive to develop superior products that meet the ever-evolving needs of their consumer base. The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

FDA Law Blog

DECEMBER 8, 2022

1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g., All packaged foods served or sold on transportation carriers (e.g., trout); and.

Genetic Engineering 59

Genetic Engineering Containment Cosmetics Protein 59

FDA Law Blog

AUGUST 27, 2023

the ability to associate the saleable return product with the transaction information/statement with the particular product). the ability to associate the saleable return product with the transaction information/statement with the particular product). Drug manufacturers have had electronic systems in place since 2017.

Packaging 52

Packaging Packaging Production Manufacturing 52

XTalks

APRIL 14, 2021

This process has been used in the food industry before, such as in cheese production, for example. Synthetic dyes are found in several food products, such as canned peas, candy and cake icing. They are also found in beverages such as sports drinks and beauty products such as mouthwash and shampoo. 1, FD&C Blue No.

Regulation 94

Regulation Production Branding Research 94

FDA Law Blog

FEBRUARY 16, 2023

Richardson — On February 15, 2023, the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) held a joint meeting to discuss an application pending before FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status. By Kalie E.

Packaging 64

Packaging Packaging Drugs Production 64

The Pharma Data

NOVEMBER 10, 2020

coli O157:H7 strain found by Michigan Department of Agriculture and Rural Development (MDARD) in Tanimura & Antle brand packaged single head romaine lettuce. brand packaged single head romaine lettuce with a pack date of Oct. recalled packaged single head romaine lettuce with a pack date of Oct. SILVER SPRING, Md. ,

Contamination 52

Contamination Packaging Packaging Production 52

pharmaphorum

DECEMBER 9, 2021

I am fascinated by the breadth of my role, which encompasses self-care products, skin health, sustainability and much more. Meanwhile, sustainability is critically important to Heather and Johnson & Johnson as a whole, prioritising sustainable packaging, ingredients, formulations and business practices with a constant eye on the future.

Allergies 105

Allergies Life Science Development Scientist 105

The Pharma Data

MAY 18, 2021

GSK Consumer Healthcare (GSKCH), the world-leading consumer healthcare business, announced today that it is partnering with two global packaging suppliers to launch fully recyclable toothpaste tubes across its specialist and science-based oral health brands, including Sensodyne, parodontax and Aquafresh. Best’ in Germany. About Albéa.

Packaging 40

Packaging Packaging Branding Cosmetics 40

FDA Law Blog

NOVEMBER 16, 2021

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

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

FDA Law Blog

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

Regulation 59

Regulation Manufacturing Packaging Packaging 59

Creogenic Pharma

MARCH 8, 2021

250+ Products. Top PCD Pharma Company provides their market with various products which are in high demand and regular use. Therefore, it is a reason we own more than 200+ products that are DCGI approved and certified by commendable institutions like FSSAI. Distributor ? Wholesaler ? Get Started with. Franchise Company.

Pharma Companies 52

Pharma Companies Production Pharma Production Marketing 52

FDA Law Blog

NOVEMBER 14, 2022

The guidance explains that a facility counts as a single facility subject to a single facility fee if it is under one management and in one geographic location and address, and is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug product. FDA stresses that the law does not provide exemptions or waivers.

Manufacturing 52

Manufacturing Packaging Packaging Production 52

FDA Law Blog

AUGUST 19, 2021

The latest version of the bill again directs FDA to establish a standard symbol system for front-of-package labeling for conventional foods. As in the past, there are a few new things of note, and a few other things have been removed (e.g., requirements for sesame allergen labeling, which was accomplished earlier this year).

Regulation 52

Regulation Containment Cosmetics Packaging 52

FDA Law Blog

JUNE 12, 2023

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. PFI has noted that it is not feasible to develop and label products for an individual state.

Regulation 45

Regulation Production Cosmetics Sales 45

Pfizer

AUGUST 15, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Herbal Products: St. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production.

Drugs 99

Drugs Vaccine Vaccination In-Vitro 99

The Pharma Data

FEBRUARY 13, 2022

The FDA took a critical step to help reduce sodium through a recently released guidance that establishes voluntary sodium reduction targets in processed, packaged and prepared foods. Today’s action, coupled with the FDA’s recent guidance, may further encourage industry to lower sodium levels in products found in schools, at home and beyond.

Cosmetics 40

Cosmetics Production Packaging Packaging 40

Pfizer

DECEMBER 13, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Herbal Products: St. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production.

Drugs 110

Drugs Licensing Licensing Production 110

Advarra

JULY 19, 2022

Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? At what point does the drug substance become a drug product? Could you please confirm?

Packaging 52

Packaging Packaging Drugs Containment 52

Pfizer

DECEMBER 20, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Herbal Products: St. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production.

Drugs 69

Drugs Licensing Licensing Containment 69

FDA Law Blog

FEBRUARY 15, 2022

FDA has adopted a tiered meeting framework not unlike the Type A, B and C meeting categories established under the Draft Guidance for meetings with sponsors of PDUFA products (the PDUFA Guidance). Meeting package content recommendations include the expected elements, but also include specific guidance on the numbering of questions.

Cosmetics 40

Cosmetics Drugs Development Regulation 40

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

pharmaphorum

OCTOBER 27, 2022

The Guidance applies to both product-related and therapeutic-area-related activities. In the EU and UK, where direct-to-consumer promotion of POMs is prohibited, companies may not sponsor blogs that promote, or could reasonably be expected to promote, such products. Digital Channels include, but are not limited to, social media ”.

Life Science 98

Life Science Medicine Regulation Compliance 98

Pharma in Brief

NOVEMBER 20, 2023

In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. 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.

Production 52

Production Cosmetics Regulation Branding 52

Pfizer

NOVEMBER 23, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Herbal Products: St. PAXLOVID is currently authorized for conditional or emergency use in more than 70 countries across the globe. Our Commitment to Access.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

FDA Law Blog

JUNE 21, 2022

Back in the 2017 user fee package, the FDA Reauthorization Act (also called “FDARA”), Congress set forth a process for establishing a category of OTC hearing aids—hearing aids that may be sold directly to patients without the intervention of a medical provider. Nor is it unusual for FDA to give FDA a deadline (which is often missed).

Regulation 52

Regulation Licensing Licensing Sales 52

FDA Law Blog

MARCH 9, 2025

The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount.

Cosmetics 59

Cosmetics Compliance Contamination Regulation 59

FDA Law Blog

JANUARY 20, 2025

This latest draft guidance outlines the Agencys recommendations for naming and labeling plant-based foods that are marketed and sold as alternatives for animal-derived foods that fall within FDAs jurisdictionnamely, plant-based alternatives to eggs, seafood, poultry, meat, and dairy products (except milk).

Production 52

Production Regulation Cosmetics Packaging 52

Pharmacy Checkers

FEBRUARY 21, 2020

On behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”.

Drugs 61

Drugs FDA Approval Manufacturing Pharmacy 61

Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. Postal Service for packages coming through IMFs. [16]. counterparts.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41