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). It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements.

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1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g., All packaged foods served or sold on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

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Genetic Engineering Containment Cosmetics Protein 57

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.

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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.

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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.”

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Regulation Manufacturing Packaging Packaging 57

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.

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Packaging Packaging Drugs Production 62

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. ,

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Contamination Packaging Packaging Production 52

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 96

Life Science Compliance Medicine Regulation 96

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.

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Regulation Production Cosmetics Sales 44

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.

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Manufacturing Packaging Packaging Production 52

Camargo

AUGUST 22, 2021

The first two were published in December of 2014: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act mandates that NDAs, ANDAs, and INDs be submitted in electronic format. The FDA published three binding guidance documents regarding the TRC.

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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).

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Regulation Containment Cosmetics Packaging 52

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.

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Pharma Companies Production Pharma Production Marketing 52

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

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.

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Regulation Production Branding Research 78

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?

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Packaging Packaging Drugs Containment 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.

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Allergies Life Science Development Scientist 105

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.

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Drugs Vaccine Vaccination In-Vitro 99

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

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.

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Drugs Licensing Licensing Production 110

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.

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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.

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Licensing Licensing Drugs Manufacturing 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.

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Sales Manufacturing FDA Approval Life Science 93

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).

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Regulation Licensing Licensing Sales 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.”.

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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.

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Pharmacy Drugs FDA Approval Licensing 41