ANDA Application Guidance Aimed At Reducing Review Times For Generics To “One Cycle”

Metabolic Disease Clinical Trial Expansion: FDA Expresses Interest in Shorter Route to Phase I for Inborn Errors

340B “Mega-Reg” In Limbo: HRSA Stresses Importance of Guidance, Promises Update When “Path Forward” Identified

FDA Promises To Finish Communication Policy Update In 2014; Does Not Sound Ready To Make Big Changes

Opioid-Induced Constipation CV Safety Review: Panel Likely To Vote For Outcomes Standard, But Leave Key Issues Up To FDA

FDA Puts Constraints on “Lower-Risk” Promotional Campaigns: Sponsors Must Have “At Least As Persuasive” Data from Post-Market to Communicate a Reduced-Risk Profile

Pathogen List for FDA Five-Year Added Exclusivity Under GAIN Antibiotic Incentives Adds Three Pathogens, Grows to 21

Regulatory Flexibility For Rare Diseases At FDA Demonstrated By Guidance To DMD Sponsors

CMS Final Hep C Screening NCD Signals Support For Long-Term Benefits Of New Therapies

Postmarket Pregnancy Registries: Panel Presses FDA to Act as Leader, Linker for Data Collection

FDA Final Breakthrough/Accelerated Approval Guidance Adds Rare Disease Language, Spells Out Manufacturing Flexibility

Postmarket Pregnancy Registries: Refinement Themes Play Key Role at FDA Public Meeting

Sanofi Cialis OTC Switch Faces Nitrate and Vision Side Effect Hurdles; Large Safety Database Has Impressed FDA Recently

E&C Health Subcommittee Moves DEA Bills on Scheduling Delays, Corrective Action Plans; Next Stop is Full Committee

Proprietary Names Draft Guidance: FDA Offers Checklists And Outlines Assessment Process As Guide To Sponsor

Advisory Committee Tracker: CV Outcomes Studies In Spotlight This Summer, With OIC Products Focus Of June Panel

Orphan Drugs and 340B: Court Ruling in PhRMA Suit Benefits Non-Orphan Drugs, May Complicate Broader 340B Regulation

Charitable Patient Assistance Programs Cannot Be Targeted To High-Price/Specialty Drugs, HHS Fraud Investigators Advise

Diabetes/Obesity Outcomes Studies: Confidentiality of Interim Analyses Will Be Subject of FDA Hearing in August

340B Impact on Medicare Under Review By MedPAC; Reps. Murphy, Ellmers Voice “Concerns” With Drug Discount Program

FDA Generic Regulatory Science Initiatives: Equivalence of Marketed ANDAs to Receive Attention As Well As Approvals

ER/LA Opioid Post Marketing Requirements: Quick Turnaround Means Creative Approaches Needed; Observational Study Approach Has Implications for Other Drug Sponsors

House “21st Century Cures” Project: Conditional Reimbursement Gets Airtime In Second Meeting

FDA Appropriations Draft Sets June 2015 Deadline For Final Abuse-Deterrent Formulation Guidance: More Zohydro Fallout

CMS Finalizes Part D Prescriber Provisions; Final Rule Defends But Does Not Include “Non-Interference” Interpretation