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.

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Compliance Regulation Packaging Packaging 52

XTalks

SEPTEMBER 17, 2020

The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. Related: FDA Announces Slow Phase-Out of Certain PFAS Chemicals Used in Food Packaging.

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Production Contamination Cosmetics Bacteria 98

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. Regulation to establish levels of allulose, polydextrose, sugar alcohols or isolated fibers above which require a warning that the food contains levels that cause “deleterious health effects.”.

Regulation 52

Regulation Containment Cosmetics Packaging 52

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). Batch steps include filter drying, milling, and packaging. FDA Guidance Addresses Real-World Evidence Data Standards.

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pharmaphorum

OCTOBER 27, 2022

Discussion Forums – If discussion forums are hosted or facilitated by a company, the company should be confident it can moderate the forum such that the content complies with relevant regulations, laws, and codes. Why is guidance needed? What are the rules on Social Media Influencers and Digital Opinion Leaders?

Life Science 98

Life Science Compliance Medicine Regulation 98

XTalks

APRIL 14, 2021

How Are Synthetic Food Dyes Regulated? 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. These include FD&C Blue No. 1, FD&C Blue No.

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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

Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3,

Packaging 52

Packaging Packaging Drugs Containment 52

Cloudbyz

OCTOBER 19, 2023

Conclusion A unified clinical trial management platform is no longer a luxury but a necessity for pharmaceutical companies aiming to thrive in an increasingly competitive and regulated industry.

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Clinical Trials Clinical Trials Trials Compliance 104

FDA Law Blog

NOVEMBER 14, 2022

It appears that some of these clarifications may reflect issues FDA has faced as some in the regulated community were surprised to receive invoices for the fee. The guidance also provides clarification about some types of facilities that are not subject to facility fees under OMUFA.

Manufacturing 52

Manufacturing Packaging Packaging Production 52

FDA Law Blog

SEPTEMBER 6, 2023

The Guidance advises that the meeting request not be submitted until “significant progress” toward remediation has been made.

Generic Drugs 44

Generic Drugs Manufacturing Drugs Cosmetics 44

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. Source link: [link].

Cosmetics 40

Cosmetics Production 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. Integrated Compliance and Governance With stringent regulations governing clinical trials, compliance is of utmost importance.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. Federal Food, Drug, and Cosmetic Act, Section 513(i)(1)(D)(i). By Philip Won & Adrienne R. But that is only the beginning. Worse, the firm only has one bite of the apple.

Packaging 75

Packaging Packaging Engineer Cosmetics 75

Cloudbyz

MAY 24, 2023

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. 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

FDA Law Blog

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. By Adrienne R. Section 207 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. Draft Guidance at 8.

Containment 40

Containment Cosmetics Packaging Packaging 40

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. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. FDA Emergency Use Authorization Statement. Herbal Products: St.

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Drugs Vaccine Vaccination In-Vitro 99

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

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. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. For more information, please visit www.PAXLOVID.com. .

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Drugs Licensing Licensing Production 110

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. Natural health product vs. regulated drug In Winning Combination Inc. In its August 16, 2023 decision in Le-Vel Brands, LLC v.

Production 52

Production Cosmetics Regulation Branding 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. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. For more information, please visit www.PAXLOVID.com.

Drugs 69

Drugs Licensing Licensing Containment 69

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. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. Our Commitment to Access. IMPORTANT SAFETY INFORMATION.

Licensing 40

Licensing Licensing Drugs Manufacturing 40

XTalks

AUGUST 2, 2023

2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13

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Sales Manufacturing FDA Approval Life Science 93

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. counterparts. J)(2) Waiver authority. for drug safety.

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Pharmacy Drugs FDA Approval Licensing 41