Tag: Guidance

FDA Statement On Policies to Understand Effects of Drugs in Pregnant and Nursing Women

It can be a challenge for health care professionals and patients to find quality scientific information about the safety of drugs and biological products when used during pregnancy or breastfeeding. E...

Updated Obligations for Drug Shortage in Australia

The Australian medicines regulator has updated its guidance on reporting obligations for pharmaceutical companies, mandating confidential reporting of all shortages. The document, published by the ...

Ph. Eur. Approved New Guide on Monographs on Vaccines and Immunosera

At its 162nd session, the European Pharmacopoeia Commission (Ph. Eur.) approved a new edition of the Guide to the Preparation and Use of Monographs on Vaccines and Immunosera for Human Use. The docume...

FDA Guidance to Support Development of Rare Diseases Treatments

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The US Food and Drug Administration (FDA) published new draft guidance to help inform the design and implementation of natural history studies that can be used to support the development of treatments...

FDA’s Guide on Immunogenicity Testing of Therapeutic Protein Products

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For the evaluation of pharmacokinetics, pharmacodynamics, efficacy and safety of biological drugs and active substances, possible immunareactions of patients are of decisive importance. Especially in ...

FDA Final Guidance – Warning of Recalls

The U.S. Food and Drug Administration (FDA) recently released the final guidance entitled “Public Warning and Notification of Recalls.” The announcement of the guidance has been published in the Feder...

REMS Assesment Guidance from FDA

On January 24, 2019, FDA published guidance on the planning and reporting of the assessment of risk evaluation and mitigation strategies (REMS) for drugs and biologics. The development of a REMS Asses...

FDA Guidance to Clarify the Role of Data Integrity in cGMP

The topic data integrity is still in the focus of international authorities. Although integrity of data has been observed since the beginning of GMP, monitoring authorities started addressing the topi...

FDA Recommendations for Submitting Human Gene Therapeutic IND Application

Human therapeutics include all products that transmit and unfold their effect through transcription or translation of transferred genetic material or through targeted modification of host/human gene s...