pharmaphorum

OCTOBER 4, 2022

The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The post Considerations for Mobile Health Technology Developers: Part 2 appeared first on. The final guidance follows the draft CDS software guidance issued on the same date in 2019.

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Development Regulation Cosmetics Life Science 105

FDA Law Blog

JUNE 10, 2024

It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA’s Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM) , both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm’s regulatory compliance.

Compliance 111

Compliance Bioequivalency Cosmetics Regulation 111

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. After platform review, if a decision is made to validate, staff should generate documentation to ensure Part 11 compliance. Public Health Service Act.

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Compliance Regulation Packaging Packaging 52

Clinical Trial Podcast

JULY 31, 2022

He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice. He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health.

Clinical Research 80

Clinical Research Clinical Trials Clinical Trials Research 80

FDA Law Blog

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

Cosmetics 59

Cosmetics Compliance Generic Drugs Regulation 59

FDA Law Blog

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution. Deb along with fellow panelists Kyle Y.

Compliance 52

Compliance Drugs Regulation FDA Approval 52

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. FDA-2021-N-1272) to inform future policy development.

Manufacturing 98

Manufacturing Regulation Compliance Production 98

pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. About the authors.

Life Science 98

Life Science Medicine Regulation Compliance 98

FDA Law Blog

JULY 13, 2021

With the approach of the January 1, 2022 mandatory compliance deadline for the BE standard, manufacturers and importers of food and dietary supplements should work to develop strategies for compliance and evaluating each product’s bioengineered (BE) status if they have not already done so.

Compliance 52

Compliance Regulation Cosmetics Manufacturing 52

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.

Clinical Trials 104

Clinical Trials Clinical Trials Trials Compliance 104

FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. FDA-2021-N-1272) to inform future policy development.

Manufacturing 75

Manufacturing Regulation Compliance Production 75

The Pharma Data

NOVEMBER 30, 2020

Food and Drug Administration (FDA) regarding the development plan for the preservative free multi-dose delivery of a proprietary Latanoprost formulation, including the clinical study design for the registration study. “We Our lead product candidates in glaucoma will pave the way for future indications across multiple programs in development.

Cosmetics 52

Cosmetics Compliance Drugs Development 52

Cloudbyz

FEBRUARY 29, 2024

Rapid Identification of Safety Signals : Timely detection of safety signals is imperative for ensuring patient safety and regulatory compliance in clinical trials. Optimization of Regulatory Reporting : Compliance with regulatory requirements is a cornerstone of pharmacovigilance activities in clinical trials.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Compliance 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. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters.

Regulation 40

Regulation Compliance In-Vitro Cosmetics 40

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

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

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. As a threshold matter, FDA lacks the power to regulate tests developed and used in a laboratory. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

Regulation 59

Regulation Genetics Cosmetics In-Vitro 59

FDA Law Blog

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

Regulation 59

Regulation Radiology Cosmetics In-Vitro 59

FDA Law Blog

NOVEMBER 6, 2023

The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. “While our attorneys don’t do this work for the recognition, it is gratifying to see their excellent work recognized.

Life Science 40

Life Science Cosmetics Regulation Drugs 40

FDA Law Blog

FEBRUARY 21, 2024

includes considerations with respect to documentation, applicable regulatory requirements, design and development, and enforcement. FDA plans to develop a new inspection process to align with the requirements of the QMSR in time to implement when the rule takes effect on February 2, 2026. The new § 820.10 Revised § 820.3

Regulation 59

Regulation Manufacturing Packaging Packaging 59

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.

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Regulation Production Cosmetics Sales 45

FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

FDA Law Blog

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). This timing undermines the Agency’s rationale that three years is enough time to come into compliance. By Allyson B. Mullen & Gail H.

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In-Vitro Regulation Production Compliance 64

Pharma in Brief

JANUARY 10, 2024

As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. The most significant legal development in 2023 was the introduction of a system of patent term adjustment ( PTA ). We also flag what to watch out for in 2024. mL formulation in Canada”.

Regulation 52

Regulation Drugs Production Medicine 52

FDA Law Blog

DECEMBER 21, 2023

Those who attended their annual Enforcement, Litigation, and Compliance Conference holiday reception earlier this month got a sneak peek at this new branding effort with the unveiling of the association’s new logo ( here ). 2024 brings a host of Hyman, Phelps & McNamara, P.C. (“HPM”)

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Branding Compliance Regulation Cosmetics 59

The Pharma Data

NOVEMBER 12, 2021

During the examination, the FDA investigator made several compliances that are outlined in an examination bonus report, also known as an “ FDA Form 483.” The FDA investigator handed a list of their compliances to the company. Source link: [link].

Cosmetics 40

Cosmetics Compliance Production Manufacturing 40

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

XTalks

JANUARY 11, 2024

The US Food and Drug Administration (FDA) has given authorization to Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug and Cosmetic Act (FD&C Act). This means Florida could soon import select prescription drugs from Canada.

Drugs 69

Drugs Cosmetics Medicine FDA Approval 69

The Pharma Data

DECEMBER 30, 2020

deputy director of the FDA’s Center for Veterinary Medicine (CVM) Division of Compliance: “Although this pet food recall is still unfolding, we are sharing the facts we have so far because the levels of aflatoxin found in the recalled pet food are potentially fatal. SILVER SPRING, Md. , SOURCE U.S. Food and Drug Administration.

Production 52

Production Cosmetics Compliance Containment 52

The Pharma Data

APRIL 28, 2022

When finalized, this product standard will: reduce the appeal of cigars, particularly to youth and young adults, and decrease the likelihood of experimentation, development of nicotine dependence, and progression to regular use; and improve public health by increasing the likelihood that existing cigar smokers may quit.

Production 52

Production Cosmetics Regulation Manufacturing 52

FDA Law Blog

JANUARY 14, 2025

By Ritte van Laack A little over two years ago, the Modernization of Cosmetic Regulation Act (MoCRA) was (at long last) enacted. Excitement that after about a decade the FDC Act finally was amended giving cosmetics more legitimacy; anxiety because MoCRA seemed a substantial change for many involved in the business of cosmetics.

Cosmetics 59

Cosmetics Manufacturing Regulation Containment 59

FDA Law Blog

FEBRUARY 12, 2023

Rather than creating its own importation program under Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act), the Food and Drug Administration (FDA) used the statute to create a pathway for States and Indian Tribes (“Sponsors”) to develop such programs (called Section 804 Importation Programs, or SIPs).

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Pharmacy Drugs FDA Approval Cosmetics 97