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 84

Life Science Compliance Regulation Cosmetics 84

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.

Regulation 94

Regulation Production Branding Cosmetics 94

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

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 45

Generic Drugs Manufacturing Drugs Cosmetics 45

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.

Clinical Trials 86

Clinical Trials Clinical Trials Trials Compliance 86

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

JUNE 12, 2023

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

Regulation 45

Regulation Production Cosmetics Sales 45

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

FDA Law Blog

MARCH 6, 2022

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

Regulation 52

Regulation Compliance Manufacturing Packaging 52

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

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

FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Revised § 820.3

Regulation 59

Regulation Manufacturing Packaging Packaging 59

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.

Drugs 99

Drugs Vaccination Vaccine 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

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

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

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

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. .

Drugs 110

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. 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

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41