FDA Law Blog

DECEMBER 8, 2022

All packaged foods served or sold on transportation carriers (e.g., On the other hand, these products are not subject to food allergen labeling requirements: Pet foods, animal feeds, cosmetics, drugs, or household cleaning products; An ingredient derived from a major food allergen that does not contain protein (e.g.,

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The Pharma Data

FEBRUARY 19, 2022

The agency is also advising that all drugs, medical devices, cosmetics and dietary supplements, regardless of packaging, be discarded. Food in non-permeable packaging (such as undamaged glass or all-metal cans) may be suitable for use if thoroughly cleaned and sanitized. 1, 2021, through the present. Source link: [link].

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FDA Law Blog

AUGUST 27, 2023

FDA intends the Guidance to provide “clarity and flexibility” to trading partners to “help ensure continued patient access to prescription drugs as the supply chain transitions to the interoperable, electronic product tracing at the package level under the DSCSA” while supporting “continued availability of products to patients.”

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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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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.

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FDA Law Blog

FEBRUARY 16, 2023

Essentially, FDA already prepared a sample DFL and made the preliminary determination that there are sufficient safety and efficacy data to support an Rx-to-OTC switch, but still needed product-specific data on the nonprescription user interface design, including packaging and labeling, to make a conclusive determination.

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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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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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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.

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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.

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FDA Law Blog

NOVEMBER 16, 2021

Gaulkin assists clients across a range of pre- and post-marketing regulatory matters relating to dietary supplements, food products, drugs, medical devices, cosmetics, pet products, and consumer products. She also assists with transactional due diligence, internal investigations, and supplier subcontracts and negotiations.

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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.

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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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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.

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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.

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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.

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FDA Law Blog

MARCH 6, 2022

To adapt ISO 13485 to the existing FDA regulatory framework, the proposed QMSR retains definitions of some terms that do not appear in ISO 13485 but are necessary to ensure alignment with the Federal Food, Drug, and Cosmetic Act (FDCA), such as the definitions for component, finished device, design validation, remanufacturer, and nonconformity.

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Advarra

JULY 19, 2022

Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? A: The FDA’s guidance document indicates the briefing package is submitted four weeks before the meeting. Q: The speaker just stated that the Meeting Package is due 60 days before the meeting date.

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FDA Law Blog

SEPTEMBER 6, 2023

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

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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].

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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.

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Creogenic Pharma

MARCH 8, 2021

With over 2800 pharma products in 8 specific divisions that have antibiotics, cardiac, diabetes, gynec, ophthalmology, dental and cosmetic and skin products, their range of products is quite varied and impressive. We provide quality packaging for all the products with proper labeling as per the norms.

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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. 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.

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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. Consumer product clinical trials typically involve the evaluation of new formulations or ingredients for safety, efficacy, and user acceptability.

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Clinical Trials Clinical Trials Production Trials 52

FDA Law Blog

NOVEMBER 9, 2021

115-521 ) amended Section 745(A)(b) for the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include that after publication of a final guidance, pre-submissions and 510(k)s “shall be submitted solely in such electronic format as specified by the Secretary in such guidance.” Draft Guidance at 8.

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FDA Law Blog

FEBRUARY 15, 2022

Meeting package content recommendations include the expected elements, but also include specific guidance on the numbering of questions. 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 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.

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Cloudbyz

AUGUST 9, 2023

The clinical research landscape is rapidly evolving. 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. This is where the platform approach comes into play.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 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. 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

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 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.

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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. 2) Botox Therapeutic/Cosmetic Botox, or botulinum neurotoxin, is a neurotoxic protein produced by the Clostridium botulinum bacteria. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13

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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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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. In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product.

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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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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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