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FSMA and Intentional Adulteration: FDA Issues Proposed Rule and Signals Approach to Economically Motivated Adulteration
…applied and are essential to prevent or eliminate a significant vulnerability or reduce such vulnerability to an acceptable level” (an actionable process step is analogous to a critical control point…
FDA Publishes Fiscal Year 2016 User Fee Rates; Only a Modest Increase in PDUFA/BsUFA Rates, But Significant Hikes for Some GDUFA Fees
…of cash for operations in the next fiscal year, and to plan ahead for submissions to FDA in the next fiscal year. Yep, you got it: it’s user fee season. …
The NPRM for the Common Rule: 88 Questions to Answer in 90 Days
…Program improvement activities (e.g., a survey of hospital patients to evaluate and improve the quality of meals delivered to hospital patients); Oral history, journalism, biography, and historical scholarship activities that…
A Hard Pill to Swallow? In Transit for a Couple of Years, FDA Finally Coughs Up Draft Guidance on Physical Attributes of Generic Tablets and Capsules
…considered when adequate justification can be provided for the size increase. These recommendations would allow an increase of one capsule size when the capsule size is less than capsule size…
DOJ Weighs in on Discount Safe Harbor
…to liability under the AKS. In the second case before Judge Zobel, United States ex rel. Banigan v. Organon USA, Inc., et al. (Case 1:07-cv-12153-RWZ), defendant Omnicare filed a reply…
Amarin Sues FDA After the Agency Denies 5-Year NCE Exclusivity for VASCEPA
…lung surfactant drug products, including SURVANTA (beractant) (NDA No. 020032), INFASURF (calfactant) (NDA No. 020521) and CUROSURF (poractant alfa) (NDA No. 020744), and other approvals where FDA applied a presumption…
Regenerative Medicine Advanced Therapy: FDA’s Newest Expedited Program Evolves to Keep Pace with Recommendations
…coverage of the Act here). You will also already know that the Center for Biologics Evaluation and Research (“CBER”) put forth its interpretation of the RAT designation program (see our…
OIG Report on FDA’s Inspections of Domestic Food Facilities: Challenges Remain
…fact ahead of the schedule as it completed inspections for almost all those facilities within three years). FDA likely can meet the requirement for the second round of inspections of…
A Meeting to Discuss FDA’s Continuing Conundrum: Innovation vs. Access
…or subject to substantial delays after approval, what marketplace dynamics dis-incentivize the marketing of approved generics? What can FDA do to help approved generics come to market? Why are there…
If Everyone’s Unhappy, Maybe You’re Doing Something Right… Comment Period on FDA’s Biosimilar Interchangeability Guidance Closes
…in all indications or uses and in all presentations. Questions are raised throughout the comments about what interchangeability actually means: is it a higher standard or just an additional data…
LDTs: The Saga Continues
…FDA’s initial statement of authority through developing a plan to regulate to LDTs, culminating in FDA’s issuance of a Discussion Draft about how LDTs might someday be regulated in the…
Griffith Bill Proposes Legislative Fix to “Route-of-Abuse” Exclusivity Block
…(NDA 208603) with labeling that includes information from clinical studies Egalet conducted discussing ARYMO ER abuse-deterrence via the intranasal route of abuse. Why? Because another company – Inspirion Delivery Technologies,…
Abuse-Deterrence and 3-Year Exclusivity: FDA Decisions Further Elucidate Scope and a “Route of Abuse” Approach to Exclusivity
…(S-016) for AlPharma Pharmaceuticals, LLC’s EMBEDA (morphine sulfate and naltrexone HCl) Extended-release Capsules (NDA 022321) should block the approval of Inspirion Delivery Technologies, LLC’s MORPHABOND (morphine sulfate) Extended-release Tablets (NDA…
FDA Issues Six Deferral Decisions for Final Health Care Antiseptic OTC Drug Monograph Ingredients
…health care personnel hand washes, health care personnel hand rubs, surgical hand scrubs, surgical hand rubs, and patient preoperative skin preparations. FDA proposed to classify all active ingredients as category…
CDRH Finalizes Post-Market Cybersecurity Guidance
…nearly all references to “essential clinical performance” to “patient harm.” This change appears to shift the way in which FDA plans to evaluate cybersecurity risk—from essential clinical performance to the…