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UK Regulatory Affairs and Pharmacovigilance: A Practical Guide to Compliance, Market Access and Product Lifecycle ManagementThe UK regulatory environment continues to evolve, creat...
Regulatory Affairs and Pharmacovigilance in India: A Lifecycle Approach for Pharma & Medical Device CompaniesIndia is a major pharmaceutical and medical device market, but succ...
Because dietary supplements are regulated by FDA as a subcategory of food, manufacturers are generally not required to demonstrate their safety or efficacy for pre-market approval....
The U.S. Food and Drug Administration (“FDA”) issued a proposed rule to update drug establishment registration and listing requirements for distributed manufacturing (“DM”) and cer...
Regulatory Affairs and Pharmacovigilance in Canada: A Lifecycle Approach for Pharma and Medical Device CompaniesIntroductionFor pharmaceutical and medical device companies entering...
New Delhi, Aug 06: In a significant step towards strengthening the integrity and transparency of India's drugs regulatory system, the Union Ministry of Health & Family Welfare...
By Larry K. Houck —
The FDA says it can't license Regenative Lab's overseas sales today because it might change its regulations tomorrow. Now, the company is suing.
CDSCO is piloting Artificial Intelligence across regulatory processes to create a faster and more data-driven regulatory system
By Adrienne R. Lenz, Principal Medical Device Regulation Expert —
On August 10, 2026, Department of Health and Human Services (HHS) Secretary Robert Kennedy made two major announcements related to the...
Earlier this month, we had shared the news of CDSCO inviting comments on the long standing problem of Brand Name Extensions (BNE) practices. While this problem is one with severe c...
A proposed rule would require companies to notify the agency about ingredients they are using, but it is unclear if the agency has the resources to vet them all.
India s specialized food processing sector is facing a severe compliance wake up call as regulatory watchdogs are urged to step in and police the increasingly blurred boundary betw...
RIs will be issued by the MAA to provide direction, and have the same authority as MAA regulation.
The FDA panel will review seven peptides and decide if they should be added to a list of substances that can be safely produced by compounding pharmacies.
RNs will be issued by the MAA to notify changes in MAA owned process, or provide operational or engineering guidance.
Agency scientists are advising against allowing widespread use of several peptide injections. Robert F. Kennedy Jr., the health secretary, has said people should be free to experim...
Manoj Joshi said restoring confidence in India's pharmaceutical manufacturing through stricter regulation is the government's immediate priority
At present, Indian firms follow their own inhouse standard to manufacture the weight-loss drug
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