Regulatory Filings and Submissions

FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.

Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.

Amgen's Phase III candidate for the treatment of psoriasis was found to clear skin lesions better than Johnson & Johnson's Stelara.

Most new injectable drugs and biologics are being designed as combination therapies, presenting difficult regulatory and production issues for manufacturers. FDA policies are encouraging this trend.

An advisory committee recommends use of the first psoriasis therapy targeting IL-17A.

FDA releases draft guidance on electronic submission of lot distribution reports.

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.

FDA draft guidances seek to maintain accurate drug information in new media.

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

FDA clarifies stability data recommendations for abbreviated new drug applications.

New formulations and expanded vaccine production are encouraged.

FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.

Genzyme plans to appeal FDA?s decision that the multiple-sclerosis treatment is not ready for approval.

The JOBS Act and FDASIA show early signs of accelerating drug development.

Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.

FDA funds research to further development of innovative generics, while working to address review and approval issues.

FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.

Innovative products and a range of indications drive the therapeutic antibody market.

Additional approvals in December have helped to outpace a recent high set in 2011.

Therapeutics targeting epigenetic mechanisms of disease will change the pharmaceutical marketplace.

Will the next US President support the backbone of our industry?

Howard Levine of BioProcess Technology Consultants talks about what industry needs to know to enter the biosimilars game in the US.

Companies often wait for a critical mass before adopting new technologies. But if no one takes the risk, critical mass will never be reached.

The FDA is launching a pilot program to allow manufacturers to electronically file drug establishment registration and drug listing information, such as ingredients, labeling, and manufacturing information.