Tech Talk

In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.

FDA’s Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.

FDA published a flurry of guidance documents in late 2016.

Top C-suite leaders are already tuning their long-range planning, hiring practices, and business systems for elasticity. Are you ready?

Translating campaign promises to predictions for bio/pharma is difficult, but optimism prevails.

Congress enacted the 21st Century Cures legislation, which shores FDA operations and supports biomedical research at the National Institutes of Health.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.

The House-approved 21st Century Cures legislation supports initiatives for medical research, drug development, and faster approvals, but comes up short on actual appropriations.

Biopharma proponents argue for FDA resources, Cures legislation, and science-based drug regulation.

The biosimilar pathway permits licensure based on less than full clinical data.

FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.

FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.

PharmTech's Editorial Director, Rita Peters, addresses the CPhI Pharma Awards' finalists at this year's CPhI Awards Gala.

Value assessment initiatives are expected to have a major impact on drug use and reimbursement.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

If FDA’s proposed generic-drug labeling rule is passed in 2017, generic drug companies would need documented processes for safety tracking and label updates.

Can Competition Block Excessive Pharma Price Hikes? EpiPen Saga Shows It’s Hard

Steep price increases for a popular drug have created patient and Congressional backlash.

Zika vaccine development is hindered by technical challenges and funding shortfalls.

FDA and industry seek speedy Congressional approval of new user fee plan.

Pressure is mounting to reduce costs and spending on prescription drugs.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

Biomedical innovation legislation may stall in 2016.

Drug manufacturing lapses undermine NIH research programs.

FDA’s breakthrough drug initiative is more popular and successful than ever.

Even though the organizers of New York’s Tribeca Film Festival decided not to air the anti-vaccine film by discredited British researcher Andrew Wakefield, the so-called documentary is getting a healthy run and further perpetuating the myth of a link between childhood vaccination and autism.

Unsafe material may remain in the US supply chain, according to a March 29th letter to FDA Commissioner Califf