Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Submissions and Approvals
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CDER Updates Policies on Expedited Review of Prior Approval Supplements

April 24, 2018

CDER released a revised Manual of Policies and Procedures on expedited reviews of prior approval supplements for new drug and biologics license applications that involve chemistry, manufacturing and controls changes. Read More

FDA Approves Tagrisso as First-Line Treatment for Lung Cancer

April 23, 2018

The drug was previously approved as a second-line treatment. Read More

Pace of FDA Generic Approvals Sharply Increases in March

April 20, 2018

The fiscal year started out strong for generic approvals – with 87, 84 and 78 approvals in October, November and December respectively. Read More

European Regulators Approve CRISPR Trial

April 19, 2018

If the procedure is successful, beta thalassemia will be the first human disease treated with the gene-editing technology in Europe. Read More

Rigel Lands FDA Approval for Tavalisse

April 19, 2018

The company plans to launch Tavalisse in May. Read More

Pace of FDA Generic Approvals Sharply Increases in March

April 18, 2018

After experiencing a steep decline early in 2018, generic drug approvals by the FDA are climbing back towards last year’s highs according to the latest FDA report. Read More

CHMP Endorses Six Medicines for Approval

April 18, 2018

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six medicines, including an orphan drug, for approval at its March meeting, in addition to three recommendations for extensions of indications. Read More

FDA Approves First Treatment for Rare Form of Rickets

April 18, 2018

The drug’s safety and efficacy were assessed in four clinical trials. Read More

Roche’s Drug Hemlibra Gets Breakthrough Designation for Hemophilia A Indication

April 18, 2018

The FDA approved the drug for treatment of hemophilia A patients with factor VIII inhibitors last November. Read More

FDA Denies Insys Petition on Stricter Requirements for Syndros Generics

April 11, 2018

Insys claimed a waiver based on equivalence with the parent drug was inappropriate because metabolite equivalence should also be measured. Read More

FDA Denies Insys Petition on Stricter Requirements for Syndros Generics

April 10, 2018

The FDA denied Insys Therapeutics’ petition asking the agency to reject abbreviated new drug applications for generics of Syndros (dronabinol) oral solution that rely on a waiver instead of establishing in vivo bioequivalence. Read More

Roche’s Tecentriq Gains NICE Recommendation After Prior Rejection

April 10, 2018

Tecentriq is a monoclonal antibody that binds with a protein, PD-L1, and stops it from camouflaging cancer cells to avoid detection and removal by the immune system. Read More

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Submissions and Approvals
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CDER Updates Policies on Expedited Review of Prior Approval Supplements

FDA Approves Tagrisso as First-Line Treatment for Lung Cancer

Pace of FDA Generic Approvals Sharply Increases in March

European Regulators Approve CRISPR Trial

Rigel Lands FDA Approval for Tavalisse

Pace of FDA Generic Approvals Sharply Increases in March

CHMP Endorses Six Medicines for Approval

FDA Approves First Treatment for Rare Form of Rickets

Roche’s Drug Hemlibra Gets Breakthrough Designation for Hemophilia A Indication

FDA Denies Insys Petition on Stricter Requirements for Syndros Generics

FDA Denies Insys Petition on Stricter Requirements for Syndros Generics

Roche’s Tecentriq Gains NICE Recommendation After Prior Rejection

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