Regulatory Filings and Submissions

FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

The new bill calls for a data exclusivity period of 15 years for drugs that treat diseases with unmet medical need.

NICE OKs biologics for the treatment of ulcerative colitis, changing its preliminary guidance that recommended against their use.

Lung Therapeutics announced that it received Orphan Drug Designation for LTI-01, an injectable designed for the treatment of loculated pleural effusion.

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.

Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.

FDA issues draft guidance on rare pediatric disease priority review vouchers in accordance with FDASIA.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FDA releases draft guidance on electronic submission of lot distribution reports.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.