FDA Promotes Complex Generics and Combination Products
To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.
Politics Drives Direct-to-Consumer Price Disclosure Rule
The US Department of Health and Human Services has published its proposed rule on the disclosure of drug prices, just in time for the November mid-term elections.
Congressional Action Alters FDA Policies, Pharma Practices
Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.
Manufacturers Face Challenges in Developing New Antimicrobials
FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.
Overhaul of New Drug Approval Process Moves Forward
CDER director plans to start implementation of new review practices by the end of 2018.
FDA Clarifies Worldwide Inspection Policies
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
Biosimilars Battles Heat Up
FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.
Quality Failures at Foreign Manufacturers Prompt Warnings and Recalls
A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.
Senate Spending Bills Give Minor Boost to FDA, Seek Price Disclosures in Ads
The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
More consistent and reliable production processes are critical for advancing innovative treatments.
FDA Opens Door to Importing Drugs
Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.
FDA Seeks to Revive Quality Metrics Initiative
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
Congress and FDA Take Action to Combat Opioid Crisis
Legislators look to widen access to medications for addiction treatment and overdose emergencies.
Congress Presses FDA to Do More to Combat Drug Shortages
Legislators have requested that FDA do more to prevent drug shortages.
Global Standard for Managing Post-Approval Changes Moves Forward
Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.
FDA Launches Overhaul of New Drug Review Program
The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
New “Right-to-Try” Law Challenges FDA Oversight
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With
President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
Precision Medicines Speed Development and Reduce Healthcare Costs
The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.
FDA Moves to Overhaul New Drug Review Process
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
Pandemic Fears Stoke Calls for New Vaccines and Global Health Initiatives
Public health authorities and the biomedical research community are seeking new strategies to address global health threats.
Budget Bill Boosts Funding for Biomedical Research and FDA Programs
Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.
FDA's Gottlieb Hits Innovators, Insurers for Blocking Biosimilar Uptake
The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.
FDA Gets Boost from Trump Budget
The Trump budget boosts funding for FDA but squeezes resources for NIH and healthcare.
Gottlieb Encourages Biosimilars and Safer Opioid Packaging
Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.
Pharma Looks to Change the Healthcare Cost Conversation
New programs and initiatives by industry examine rising healthcare costs.
Trump Blasts Drug Prices, Sidesteps Health Reform
The President described US drug costs as unfair and stated that prices will come down.
Using Prior Knowledge in Biotechnology Testing
FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.
Drug Pricing Dominates Senate Hearing on HHS Nominee Azar
Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?
Tax Overhaul a Plus for Pharma
New tax legislation may result in savings for biopharma companies.
