Remove Compliance Remove Pharmacy Remove Regulation
article thumbnail

Breaking Down the Cost of Generic Drug Production: Understanding the Factors Influencing Affordability

Drug Patent Watch

Factors such as raw material sourcing, manufacturing costs, regulatory compliance, and distribution networks all contribute to the final price of the generic medication. Regulatory compliance is another significant factor influencing the affordability of generic medications. Sounds straightforward, right?

article thumbnail

Can J&J’s vaccine approval erase bad pharma?

World of DTC Marketing

SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. Johnson & Johnson has paid $2.7 billion in penalties. Ethical leadership!

Vaccine 180
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. This post examines the Zarzamora pharmacy and prescribing red flags decision. d/b/a CVS/Pharmacy, Nos.

Pharmacy 139
article thumbnail

Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit

FDA Law Blog

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

article thumbnail

CDER’s Office of Compliance Kicks Off Annual Report Season with Rundown of 2023’s Major Public Health Enforcement Initiatives

FDA Law Blog

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. By John W.M. Drug Supply Chain. Clinical Trials.

article thumbnail

Precision Compounding Pharmacy’s Unique Role in Telemedicine Fulfillment

XTalks

In an era where telemedicine is rapidly transforming the landscape of healthcare, Precision Compounding Pharmacy stands out as a beacon of innovation and excellence. Under the leadership of CEO Christian Stella , PharmD, Precision has carved a niche for itself, not just as a pharmacy but as a vital player in the telemedicine ecosystem.

article thumbnail

Advancing and Safeguarding Clinical Research for a Better Tomorrow

Advarra

Food and Drug Administrations (FDA) regulations on good clinical practice, which are based on ethical standards outlined in frameworks such as the Belmont Report and the Declaration of Helsinki. Industry-Leading Ethical Standards Advarra is organized and operates in compliance with U.S.