Drug Discovery World

AUGUST 24, 2023

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. However, the substance has shown promise in the field of medicine for a range of diseases and conditions, making its legality a debating point within the drug discovery industry internationally.

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Clinical Trials Treatment Regulations Trials 130

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.

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Science FDA Packaging Production 40

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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FDA Production Regulations Vaccine 40

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). A Florida trial court, in Brookes v. at 77 (citation omitted). In United States v. Brown , 348 F.3d

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