Jill Wechsler

Leading US senators are proposing legislation to add Ebola to the list of diseases eligible for priority review vouchers from FDA as an incentive for biopharmaceutical companies to invest in treatments for this deadly disease.

After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), has administration approval for organizational changes to bolster programs and policies to ensure drug quality.

After almost two years of discussion and analysis, FDA is finalizing a proposal for collecting data from manufacturers to help measure the performance of manufacturing operations and the quality of resulting drugs and biologics.

Demand for new therapies and vaccines spotlights production challenges.

To encourage adoption of advanced manufacturing technologies that can help industry meet high quality standards consistently, and avoid drug recalls and shortages, FDA’s Center for Drug Evaluation and Research is establishing an Emerging Technology Team (ETT) to assist innovative manufacturers in navigating the regulatory process and overcome roadblocks.

FDA demands accurate manufacturing and test information to ensure product quality.

A surge in generic drug applications is testing FDA?s ability to reduce the backlog of ANDAs.

The development of new treatments and preventives to combat the lethal Ebola virus has been slow, marked by caution at public health agencies to approve testing of high-risk compounds, and reluctance of biopharmaceutical companies to invest in a field with limited market potential. All that has changed now, as thousands of people have been sickened by the virus, and the death rate has escalated.

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

After months of speculation about prospects for biosimilar development in the United States, Novartis announced on July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim).

A potential treatment for sickle cell disease has come through the “valley of death” of early-stage development due to support from a collaborative partnership established by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH).

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Regulators and industry organizations explain policies and standards to manufacturers and authorities across the globe.

The Rx360 pharmaceutical supply chain consortium celebrated its first five years with an anniversary conference the week of June 5, 2014 in Washington, D.C. The conference featured key FDA officials and industry leaders.

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

A national publicity campaign recently succeeded in obtaining early access to an experimental treatment for a seriously ill child, touching off a broader discussion of compassionate use policies and their impact on drug development and approval.

New identifiers and tracking requirements aim to block illegitimate products.

New formulations and expanded vaccine production are encouraged.

In anticipation of the 200th anniversary of the United States Pharmacopeia (USP) in 2020, the organization’s new leadership is taking a fresh look at its role in setting standards for pharmaceutical development and production and how that has been altered by new regulatory policies and industry globalization.

Even though the just-released Medicare data on payments to individual doctors.

A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled, and CDER leaders are looking for experienced industry managers to help rebuild its staff.

New identifiers and tracking requirements aim to block illegitimate products.

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy, and clinical utility of companion diagnostic tests.

In an abrupt about-face, the Obama administration halted its ill-timed effort to launch an overhaul of the Medicare Part D program and announced it would not pursue changes in some key rules as proposed earlier this year.

Despite a slight boost in funding for the Food and Drug Administration and stronger tax incentives for investment in R&D, significant changes in Medicare drug reimbursement and coverage policies have biopharmaceutical companies up in arms.

Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight.

Accelerated testing and production create challenges in documenting product quality.

Despite notable successes in preventing and mitigating short supplies of important medicines, the drug shortage crisis still disrupts medical treatment and gives drug manufacturers a bad name.

The Food and Drug Administration plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014.