XTalks

APRIL 14, 2021

The US Food and Drug Administration (FDA) defines color additives as “any substance that imparts color to a food, drug, cosmetic, or the human body. These labels must be present on the packaging of the items sold. They are also found in beverages such as sports drinks and beauty products such as mouthwash and shampoo.

Regulation 94

Regulation Production Branding Research 94

Cloudbyz

OCTOBER 19, 2023

The pharmaceutical industry plays a critical role in improving healthcare by developing and bringing new medicines to market. Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount. In recent years, the need for a unified clinical trial management platform has become increasingly evident.

Clinical Trials 104

Clinical Trials Clinical Trials Trials Compliance 104

pharmaphorum

DECEMBER 9, 2021

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

Creogenic Pharma

MARCH 8, 2021

Top PCD Pharma Company provides their market with various products which are in high demand and regular use. The distributor or the channel partner of these companies takes care of the distribution, selling, advertising, and other market support. They are also engaged in the marketing of our goods to cover possible horizons.

Pharma Companies 52

Pharma Companies Production Pharma Production Marketing 52

FDA Law Blog

JULY 10, 2023

The AI response package must respond completely to all parts of the deficiencies and include all information needed to address the deficiencies; in other words, a firm cannot submit a partially completed response package and plan to submit another AI response package at a later date to address remaining deficiencies.

Packaging 75

Packaging Packaging Engineer Cosmetics 75

Cloudbyz

MAY 24, 2023

This is where unified clinical trial management solutions come into the picture, enhancing efficiency, reducing time to market, and ensuring high-quality, scientifically validated consumer products. Time to Market: Consumer products operate in a highly competitive market where time is of the essence.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

FDA Law Blog

NOVEMBER 14, 2022

Specifically, the guidance states that FDA considers overpackaging to be the enclosure of individual drug products that each bear full and complete labeling information required under the FDC Act to allow legal marketing individually.

Manufacturing 52

Manufacturing Packaging Packaging Production 52

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.

Generic Drugs 45

Generic Drugs Manufacturing Drugs Cosmetics 45

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. By Riëtte van Laack — FDA regulates pet food similar to other animal foods.

Regulation 45

Regulation Production Cosmetics Sales 45

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. PAXLOVID is generally administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days.

Drugs 110

Drugs Licensing Licensing Production 110

FDA Law Blog

FEBRUARY 15, 2022

A meeting that is necessary to address an important safety issue that needs immediate action when the meeting requester learns about a safety issue related to an OTC monograph drug that is marketed or being developed. By Deborah L. FDA notes that it generally will not provide preliminary responses for Type X meetings.

Cosmetics 40

Cosmetics Drugs Development Regulation 40

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. PAXLOVID is generally administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days.

Drugs 69

Drugs Licensing Licensing Containment 69

XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. 2022 Revenue: Pfizer reported an annual revenue of $100.33 Pfizer Inc.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

pharmaphorum

OCTOBER 27, 2022

Websites – Companies can use appropriate search engine optimisation (SEO) and marketing tools to ensure that their websites are displayed high on the list of results for relevant key word searches. Therefore, companies are encouraged to establish a methodology for calculating fair market value rates. About the authors.

Life Science 98

Life Science Medicine Regulation Compliance 98

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. PAXLOVID is currently authorized for conditional or emergency use in more than 70 countries across the globe. Our Commitment to Access. IMPORTANT SAFETY INFORMATION.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

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

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