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.

Compliance 52

Compliance Drugs Regulation FDA Approval 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

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.

Life Science 98

Life Science Compliance Regulation Cosmetics 98

FDA Law Blog

NOVEMBER 6, 2023

Research for the guide was based on 1,000s of interviews and surveys completed by law firm partners active in the market. Our knowledge of the laws and regulations governing drugs, medical devices, foods, dietary supplements, and cosmetics is unparalleled in breadth and depth. life sciences industry.

Life Science 40

Life Science Cosmetics Regulation Drugs 40

FDA Law Blog

MARCH 24, 2024

PhRMA argued that Congress established the 340B drug discount program, imposed ceilings on prices drugmakers may charge certain healthcare facilities, specified what those facilities are, and provided compliance and enforcement mechanisms for manufacturers and covered entities. . § 23-92-604(c)(1), (2) (Act 1103).

Pharmacy 59

Pharmacy Manufacturing Drugs Regulation 59

FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021). By Sophia R.

Containment 45

Containment Contamination Compliance Manufacturing 45

FDA Law Blog

DECEMBER 6, 2023

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. We’ve previously written about this proposed rule (see here , here , and here ) which would transform the diagnostic market in the United States.

Regulation 59

Regulation Genetics Cosmetics Compliance 59

Cloudbyz

OCTOBER 19, 2023

Enhanced Collaboration: A unified platform fosters better communication and collaboration among research teams, sponsors, investigators, and other stakeholders. Regulatory Compliance: Streamlining processes aids in meeting stringent regulatory requirements and maintaining data integrity.

Clinical Trials 89

Clinical Trials Clinical Trials Trials Compliance 89

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. Summaries of the most striking recently released Warning Letters are included below. Shah, M.D.,

Manufacturing 59

Manufacturing Production Drugs FDA Compliance 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

SEPTEMBER 11, 2020

This is due to these companies violating the Federal Food, Drug and Cosmetic Act which was passed in 1938 to give the FDA authority to oversee the safety of drugs. . The FDA has issued warning letters to 17 websites for illegally selling unapproved or misbranded opioids. . Conor Kavanagh. Source link.

Cosmetics 52

Cosmetics Compliance Pharmacy Doctors 52