FDA Gives Thorough Reassessment, Reiteration of No-Compounding For Adenosine Phosphates, Chloramphenicol

Generic Labeling Rule: Industry Alternative Will Be Presented During March Hearing; Comment Period Reopened

FDA Compounding MOU Starts The Enforcement Clock On Large Compounders; Outsourcing Facilities Guidances Clarify Process

Compounding Guidances: FDA Repackaging Position Would Permit Continued Avastin Compounding In Smaller Doses

FDA To Create Biomarker Wish List: Survey Seeks Candidates For Qualification, With Eye To PDUFA VI, “Cures” Initiative

E&C Committee Passes DEA Scheduling Bill: New Version Extends Brand Exclusivity To Make-Up For Scheduling Delays

Alcoholism Treatment Guidance: FDA Allows “No Heavy Drinking” Endpoint in Lieu of Abstinence

CMS Returns To Part D Rule: Finalizes Relatively Minor Program Changes and Steers Clear of Controversial Policy Areas

FDA Sentinel Network Has Reached “Production System” Stage; CDER Wants To Restrict Sentinel To Safety Tool

Infliximab Biosimilar Advisory Committee Is March 17; Hospira Seeks Extrapolation to All Remicade Indications

Mikulski Research Bill Increases NIH Funding Over Six Years; Warren Bill Formally Introduced

FDA Undertakes Effort To Clean Up, Clear Up ANDA, 505(b)(2) Procedures; Big Project To Reduce Delays in Generic Approvals

340B Mega-Guidance Projected For June, “Several” Manufacturer Audits Likely This Year; HRSA Lists Orphan Discount Deniers

FDA Entering Caretaker Phase Or Moving To New Duarchy? Chief Scientist Ostroff To Serve In Interim After Hamburg’s Departure

Biologics 12-Year Exclusivity “Not Yet Settled” In Trade Agreement, HHS’ Burwell Says; Hatch To Propose Carving Out CMS From HHS

DEA Scheduling Bill Passes Health Subcommittee With 45-Day Interim Final Rule Approach; Senate Working with FDA, DEA

FDA Shortens IND Form to Expand Access To “Expanded Access”

FDA FY2016 Budget Focus Is Foods, Not Drugs; “Precision Medicine” Funding For Diagnostics

President’s FY16 Budget Proposal Includes Prohibition for Additional Biologics Exclusivity Due to “Minor Changes”

Combination Product Reviews Get Attention In “21st Century Cures” Draft; Low Profile Issue May Have Big Impact For Pharma

FDA Staffing Is Big Hole In 21st Century Cures Draft; Agency’s First Burden Is Defending Policy – With More Tasks To Come

Expanded Access Programs Would Increase Under 21st Century Cures: Companies Can Devise Timelines For Responding

21st Century Cures on CMS, Medicare: Transparency and Communication Emphasized; Dangerous Turf As Bill Progresses

Obama Precision Medicine Initiative Includes $10 Million to FDA for Databases, Evaluation of NextGen Sequencing

“Breakthrough” Approval Is Big Idea In “21st Century Cures”; Biomarker, Platform Approval Sections More Likely To Survive