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CFSAN Priorities for 2013-2014 Include FSMA, Food Labeling, NDIs, Energy Drinks, and Cosmetic Safety
…understanding of the usefulness of a food or a category of foods in maintaining healthy dietary practices”); CFSAN also plans to issue final guidance about labeling foods made without bioengineered…
FDA’s Office of Generic Drugs Says “We Hear You, and We’re Willing to Bite the Bullet” in a Massive Effort to Address Post-GDUFA Stakeholder Transparency Concerns
…of FY 2017. It also includes ANDAs submitted to FDA in the full year 1 (Fiscal Year 2013) and partial year 2 (Fiscal Year 2014) GDUFA cohorts. These two GDUFA…
FDA Seeks Information on Safety and Effectiveness of Nanodevices
By Ricardo Carvajal – FDA announced a public workshop intended to help the agency gather information on the safety and effectiveness of medical devices that use nanotechnology. FDA posted questions…
CDRH Releases 2014-2015 Strategic Priorities
…a plan for determining the devices for which data requirements may be shifted from pre to postmarket. This plan involves reviewing all device types subject to PMA approval “to determine…
CDRH Announces Expedited Access PMA Program to Speed Development and Approval of Devices that Treat or Diagnose a Life-Threatening or Debilitating Disease and Meet an Unmet Medical Need
…as Phase 1, and organizational commitment from FDA involving senior managers. Accelerated Approval: Accelerated approval provides for drug approval based on an effect on a surrogate or intermediate clinical endpoint…
Rules? Where We’re Going, We Don’t Need Rules: FDA Goes Back to the Future With Recent Hatch-Waxman Policy Shifts; What’s a Company to do?
…patent certification without the engineered delay of FDA’s MMA regulation at 21 C.F.R. § 314.94(a)(12)(viii)(C)(1)(ii). Prior to the “valid Paragraph IV certification” regulation companies would submit so-called “serial Paragraph IV…
Sex Matters: Research for All Act Seeks to Facilitate the Research, Development, and Approval of Drugs With an Eye Towards Male and Female Differences
…Society for Women’s Health Research, which has also held a congressional briefing on the need for sex- and gender-based research. Other organizations have also recently pressed for sex-specific clinical research…
RICO Challenges to Drug Co-Pay Programs Fall Like Dominoes: Another Federal Court Judge Dismisses RICO Claim
…of those cases. This lawsuit is one of several filed by various union health plans alleging that brand-name drug-makers violated RICO when they provided co-pay subsidy coupons to privately-insured consumers…
Fitting New Scientific Advances Into an Old Regulatory Paradigm: Fusion Proteins and Orphan Drug “Sameness”
…science that allow researchers to target rare diseases that were previously not readily amenable to therapy. This is good news. It is a reflection of substantial medical progress that’s allowing…
GAO Identifies Gaps in Oversight of Use of Medically Important Drugs in Food Animals
…some resistance in bacteria is caused by antibiotic use in food animals (cattle, poultry, swine). In the last decade, federal agencies including FDA and APHIS, have taken a number of…
The President Signs 21st Century Cures into Law; Highlights of Drug and Biologic Related Provisions (Part One)
…under this section may be used for obtaining approval under an NDA or BLA, or supporting investigational use of a drug or biologic under an IND. The section also allows…
Legislators Want GAO Studies on Non-Biologic Complex Drugs & FDA Inspections, and Want a Raft of Documents as Questions are Raised About ANDA Review Efficiency
…example, FDA’s GDUFA Regulatory Science Priorities for Fiscal Year 2016 include the following: Equivalence of complex drug products includes research into making generic versions available in all product categories, including…
Question: What do Sodium Reduction, FOP Labeling, and Medical Foods Have in Common?
…heart disease, site specific cancers, diabetes, hypertension, osteoporosis, age-related macular degeneration, neural tube defects, and dental caries.” One of the principal objectives of the NRP was to develop a proposed…
Clearing the Air on Pre-GDUFA Year 3 ANDAs; OGD Issues Revised (and Much Improved) Communications MAPP
…lack goal dates. This makes it hard for applicants to plan product launches and conduct other business planning that affects generic drug availability. To facilitate launch planning – and help…
FDA Issues Long-Awaited QMSR Final Rule
…Regulation (QMSR) Final Rule. The final rule emphasizes risk management activities and risk-based decision making. It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing…