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. Therefore, companies are encouraged to establish a methodology for calculating fair market value rates.

Life Science 91

Life Science Compliance Regulation Cosmetics 91

Pharma in Brief

JANUARY 7, 2024

Section 804 Importation Programs On October 1, 2020, the FDA published a rule entitled Importation of Prescription Drugs (the US Importation Rule ) to implement Section 804 of the Food, Drug, and Cosmetic Act. Biologics, controlled substances, and certain other drugs are not eligible for importation. 01.014.13).

Drugs 52

Drugs Regulation FDA Approval Manufacturing 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”)

Branding 59

Branding Compliance Regulation Cosmetics 59

Advarra

JULY 26, 2022

Even though CBD and cannabis usage has grown, and marketing claims have proliferated regarding potential therapeutic applications, there is still little research on their effects on the human body. Drug Enforcement Administration (DEA), meaning it has no accepted medical use and a high potential for abuse. Funding Research on Cannabis.

Regulation 97

Regulation Research Production Cosmetics 97

FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Patcos Cosmetics Pvt. market complaints in 2021 through 2023 but could not provide documentation to demonstrate how the complaints were reviewed or evaluated.

Manufacturing 59

Manufacturing Production Drugs FDA Compliance 59

FDA Law Blog

DECEMBER 6, 2023

We’ve previously written about this proposed rule (see here , here , and here ) which would transform the diagnostic market in the United States. The Federal Food, Drug, and Cosmetic Act simply did not confer that power upon FDA. The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R.

Regulation 59

Regulation Genetics Cosmetics Compliance 59

Cloudbyz

OCTOBER 19, 2023

The pharmaceutical industry plays a critical role in improving healthcare by developing and bringing new medicines to market. Regulatory Compliance: Streamlining processes aids in meeting stringent regulatory requirements and maintaining data integrity.

Clinical Trials 84

Clinical Trials Clinical Trials Trials Compliance 84

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. Analogous testing handed by Philips Respironics to the FDA on bias authorized for marketing in theU.S.

Compliance 40

Compliance Cosmetics Production Manufacturing 40

Camargo

SEPTEMBER 8, 2021

Of particular concern was a component in the previous iteration that placed product sponsors at a potential compliance risk if the sponsor simply had knowledge of an off-label use of their product. The regulation has been in flux since 2015. The regulation has been in flux since 2015. PDUFA Fees for Fiscal Year 2022 Announced.

Development 186

Development Regulation Production Drugs 186

FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

Generic Drugs 45

Generic Drugs Manufacturing Drugs Cosmetics 45

FDA Law Blog

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks. More than a few have taken far longer—literally decades.

FDA Approval 40

FDA Approval Production Drugs Generic Drugs 40

FDA Law Blog

AUGUST 17, 2022

Thus, only self-fitting hearing aids need to be cleared by FDA prior to marketing; regular OTC hearing aids—ones that are customizable based on user preference—do not, and consumers must rely on FDA postmarket enforcement activities to ensure safety and effectiveness of OTC hearing aids (more on that later).

Licensing 40

Licensing Licensing Regulation Marketing 40

Pharma in Brief

JANUARY 10, 2024

Changes in Canada’s pricing and market access regimes This year saw major developments in the drug price and reimbursement space, including at the Patented Medicine Prices Review Board ( PMPRB ), the pan-Canadian Pharmaceutical Alliance ( pCPA ), and the Canadian Agency for Drugs and Technologies in Health ( CADTH ).

Regulation 52

Regulation Drugs Production Medicine 52

FDA Law Blog

FEBRUARY 29, 2024

If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R.

Production 59

Production Drugs FDA Approval Compliance 59

FDA Law Blog

OCTOBER 25, 2021

In 1997, the de novo classification process was added to the Federal Food, Drug, and Cosmetic Act (FDCA) by the Food and Drug Administration Modernization Act of 1997. befitted a very important pathway to market for novel medical devices. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. Part 860.

Regulation 52

Regulation Manufacturing Cosmetics Compliance 52

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). Criteria for regulation. The FDA interprets “pattern” to refer to multiple, sequential, or repeated measurements of a signal or from a signal acquisition system. Criterion 2.

Development 98

Development Regulation Cosmetics Life Science 98

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.

Regulation 45

Regulation Production Cosmetics Sales 45

FDA Law Blog

OCTOBER 6, 2023

These products are devices as defined in section 201(h) (1) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act, including when the manufacturer of these products is a laboratory.

In-Vitro 64

In-Vitro Regulation Production Compliance 64

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.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81