Common Sense for Drug Policy Blog

JANUARY 5, 2024

Melatonin, the hormone involved in the regulation of our biological clock, is released when we are exposed to daylight. Historians trace the use of coffee back to the fifth century, in the Sufi monasteries of Mocha, now known as Yemen (Weinberg and Bealer 2001 ). As Crary ( 2013 , p. But working at night is not necessarily good for us.

Pharmacy 52

Pharmacy Regulations Production Marketing 52

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting.

FDA 40

FDA Trials Therapies Regulations 40

Policy Prescription

JANUARY 31, 2022

state boards of pharmacy to properly regulate pharmacies that irresponsibly and too often illegally profited from opioid drug sales to patients. So, where was the West Virginia Board of Pharmacy? This post should serve as the beginning of a serious inquiry into the failure of U.S. It’s really straightforward.

Pharmacy 52

Pharmacy Regulations Doctors Drugs 52

Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. Most recently, Regulation (EU) 2022/123 requires the EMA to monitor shortages that could lead to crisis situations.

Regulations 40

Regulations Production Packaging FDA 40

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science 40

Science FDA Production Packaging 40

Drug & Device Law

JANUARY 4, 2024

Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d 341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. 4th 902, 905 (11th Cir.

Vaccine 59

Vaccine FDA FDA Approval Production 59

Drug & Device Law

OCTOBER 26, 2023

341 (2001) (a Bone Screw case). Plaintiffs constantly seek to create FDCA violations that do not exist, often through bizarre interpretations of FDA regulations that the FDA has never followed. That’s exactly how we attacked – and usually beat – FDCA-based negligence per se claims before we won the preemption ruling in Buckman Co.

Regulations 59

Regulations Doctors FDA Drugs 59