pharmaphorum

OCTOBER 27, 2022

Jackie Mulryne, Partner, is a member of the Life Sciences practice group, and provides regulatory, policy, and compliance advice to clients in the pharmaceutical, medical technology, cosmetics, and foods sectors. The post New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry appeared first on.

Life Science 98

Life Science Medicine Regulation Compliance 98

XTalks

APRIL 14, 2021

The color cyan blue is not easy to find in nature, making this discovery significant for the industry’s innovation and developments. Scientists used synthetic biology and computational protein design tools to develop an enzymatic process to transform red cabbage anthocyanins into their desired color. 1, FD&C Blue No.

Regulation 94

Regulation Production Branding Research 94

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

FDA Law Blog

NOVEMBER 16, 2021

Baumhardt develops regulatory strategies, prepares pre-submissions and regulatory market authorization submissions, drafts regulatory policies and procedures, and reviews advertising and promotional materials. In the pre-market area, Ms.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

Advarra

SEPTEMBER 8, 2022

This applies to electronic data and signatures submitted under records requirements under other regulations such as: Federal Food, Drug, and Cosmetic Act. A documented review of the vendor’s validation package will allow your company to decrease its burden of validation. Public Health Service Act.

Compliance 52

Compliance Regulation Packaging Packaging 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

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

Advarra

JULY 19, 2022

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? Q: The speaker just stated that the Meeting Package is due 60 days before the meeting date.

Packaging 52

Packaging Packaging Drugs Containment 52

Cloudbyz

MAY 24, 2023

Consumer products companies constantly strive to develop superior products that meet the ever-evolving needs of their consumer base. The trials span several categories of consumer products such as cosmetics, personal care products, nutrition supplements, food, beverages, and consumer health products.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

FDA Law Blog

FEBRUARY 15, 2022

OTC monograph order requests or OMORs), other matters relevant to the regulation of nonprescription drugs, and the development of new nonprescription drugs under section 505G. Specifically, Type X meetings are limited to: A meeting that is necessary for an otherwise stalled OTC monograph order development program to proceed.

Cosmetics 40

Cosmetics Drugs Development Regulation 40

FDA Law Blog

NOVEMBER 9, 2021

As that program was underway, FDA developed another pilot program for electronic 510(k)s using the electronic submission template and resource (eSTAR). It defines an electronic submission, or eSubmission, as a “submission package produced by an electronic submission template that contains the data of a ‘complete’ submission.”

Containment 40

Containment Cosmetics Packaging Packaging 40

Cloudbyz

AUGUST 9, 2023

As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. The clinical research landscape is rapidly evolving. This is where the platform approach comes into play.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

FDA Law Blog

FEBRUARY 16, 2023

With the Rx-to-OTC switch objective in mind, FDA took the “ unprecedented ” step of developing and testing a model drug facts label (DFL) for OTC naloxone and published a label comprehension study and model DFLs for naloxone administered via nasal spray and auto-injector in 2019. including a QR code that links to additional training).

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

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. One of the FDA’s signature efforts to improve our nation’s nutrition is focused on reducing the level of sodium in the food supply. Related Information.

Cosmetics 40

Cosmetics Production Packaging Packaging 40

Pfizer

DECEMBER 20, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Loss of therapeutic effect of PAXLOVID and possible development of viral resistance. For more information, please visit www.PAXLOVID.com.

Drugs 69

Drugs Licensing Licensing Containment 69

Pfizer

DECEMBER 13, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Loss of therapeutic effect of PAXLOVID and possible development of viral resistance . For more information, please visit www.PAXLOVID.com. .

Drugs 110

Drugs Licensing Licensing Production 110

XTalks

AUGUST 2, 2023

is a global pharmaceutical company, working across both developed and emerging markets. 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. Pfizer Inc.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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

Pfizer

AUGUST 15, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Loss of therapeutic effect of PAXLOVID and possible development of viral resistance. FDA Emergency Use Authorization Statement. 08.11.2022.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

Pfizer

NOVEMBER 23, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Loss of therapeutic effect of PAXLOVID and possible development of viral resistance. Our Commitment to Access. IMPORTANT SAFETY INFORMATION.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

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