Your search returned 37 results

{0} results
{0} result

Blog Post

FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are...

Quick view Full view

Blog Post

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from...

Quick view Full view

Blog Post

MDR and IVDR: MedTech Europe calls for an extension of the transitional provisions

On 27 July 2018, the European trade association representing the medical technology industries, MedTech Europe, issued a position paper in which the association requests the European...

Quick view Full view

Blog Post

Access to documents held by EMA: access requests by non-EU applicants to cease

The EMA has announced that, from 15 June 2018. The Agency will cease to accept requests for access to documents by non-EU applicants. The EMA announced that the Agency’s decision was...

Quick view Full view

Blog Post

FDA aims to foster gene therapy developments with six new draft guidance documents

This morning, FDA’s Center for Biologics Evaluation and Research (CBER) published six draft guidances relating to gene therapy, three of which cover products for specific disease...

Quick view Full view

Blog Post

EMA provides guidance on the sponsor’s role in validating electronic systems used in clinical trials

The European Medicine Agency (EMA) has updated its Good Clinical Practice (GCP) Guideline[1] to clarify the level of validation/qualification that needs to be performed by a sponsor in a...

Quick view Full view

Blog Post

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal products and biosimilars

The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorizations from stakeholders

Quick view Full view

Blog Post

Institutional Review Board “Checklist” offers tool to help protect clinical trial participants

On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). The agencies are...

Quick view Full view

Blog Post

FDA shows that it means business in stopping stem cell clinics that put patients at risk

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic...

Quick view Full view

Blog Post

FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological ...

Quick view Full view

Blog Post

Italy: Formulation patents may prevent reimbursement of generics… but, are you innovative enough?

The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of...

Quick view Full view

Blog Post

Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials in emergency situations

On December 14, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes ...

Quick view Full view

No results found for the matching keyword.

;
Loading data