Regulatory Strategy and FDA Policy
The development of drugs, biologics, and medical devices follows rigorous paths to ensure safe and effective medicines. We create FDA regulatory engagement strategies and help clients interpret FDA regulations, guidance, and the likely impact of legislation. Interpreting FDA priorities, resources, User Fee Acts, and label and promotion requirements, our experts can help you manage your pipeline.
The Three Rs of Diagnostics and Personalized Medicine: Regulatory, Research, and Reimbursement
Avalere will be hosting a conference on the future of market access for diagnostics and personalized medicine.
FDA Releases Long-Awaited Guidance on Laboratory Developed Tests
On July 31, FDA released the details of its draft guidance regulating laboratory developed tests (LDTs).
Differences in FDA Communication Practices Result in Increased Review Times for Devices
As the medical device industry prepares for the next round of user fee negotiations, manufacturer representatives must consider the importance of FDA's approval process transparency, and regular interactive communication.
Diagnostic Laboratory Industry Negotiates FDA’s Revised Standards
As the laboratory testing community continues to weather recent policy changes in both regulatory and reimbursement areas - there has been yet another development.
FDA Releases Draft Guidance for Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
On May 13, FDA released a draft guidance describing the clinical pharmacology data needed to support a demonstration of biosimilarity to a reference product.
FDA Advisory Panel Unanimously Recommends Exact Sciences’ Cologuard®, the First Product to Undergo FDA-CMS Parallel Review
On March 26 and 27, FDA's Advisory Panel reviewed two DNA-based colorectal cancer (CRC) screening tests, Epigenomics-Epi proColon® Septin 9 test and Exact Sciences-Cologuard®.
FDA Releases Draft Guidance for Conducting Bioavailability and Bioequivalence Studies
On March 18, FDA released draft guidance containing recommendations for sponsors and new applicants preparing bioavailability (BA) and bioequivalence (BE) data for products in investigational new drug applications (INDs), new drug applications (NDAs) and NDA supplements.
FDA to Hold Public Hearing on Issues and Challenges Associated with Demographic Subgroup Data
FDA will hold a public hearing on April 1 to receive feedback from key stakeholders on 1) demographic subgroup representation in clinical trials, 2) analysis of demographic subgroup data, and 3) communication of demographic subgroup information to the public.
FDA Confirms Widespread Generic-Drug Equivalency Testing Program
FDA has now confirmed that the first widespread generic-drug equivalency testing program was initiated last September (without public notice).
FDA Releases Draft Guidance on New Chemical Entity (NCE) Exclusivity Determinations For Combo Drugs
On Feb. 24, FDA issued draft guidance on exclusivity determinations for certain fixed-combination drug products (FCDs).
FDA Releases Final Guidance on Pre-Submission Program for Medical Devices
On Feb. 18, FDA released guidance outlining how an applicant can obtain FDA feedback on a potential or planned medical device submission reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), including the Pre-Submission (formerly pre-Investigational Device Exemption (pre-IDE)) program.
GAO and FDA Release Separate Reports on Drug Shortages; Disagreement Over Number of Ongoing Drug Shortages
On Feb. 10, the Government Accountability Office (GAO) released a report discussing the results of its drug shortages analysis, and reported that although the total number of ongoing drug shortages continues to increase, new drug shortages decreased in 2012.
FDA Releases Draft Guidance on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Drugs and Biologics
On Jan. 14, FDA issued draft guidance for industry called "Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics."
FDA Releases Final Guidance on Qualification Process for Drug Development Tools
On Jan. 6, FDA released final guidance outlining the qualification process for drug development tools (DDTs).
Brenda Huneycutt to Moderate FDA Panel at the 2014 Biotech Showcase in San Francisco
Join Avalere's Brenda Huneycutt, FDA Policy & Regulatory Strategy Practice, who will be moderating a panel with Avalere's Jenny Gaffney and other leading experts at the Biotech Showcase in San Francisco on Tuesday, January 14th at 8am, titled "FDA: where it's going and how it affects biotech."
FDA Solicits Comments on Draft Guidances Regarding Compounding Facilities
On Nov. 27, FDA released three draft guidances on the regulation of compounding pharmacies following the enactment of the Drug Quality and Security Act (DQSA).
FDA Issues Warning Letter to 23andMe Genomic Service; Other LDTs on the Radar?
On Nov. 22, FDA issued a warning letter to 23andMe, Inc., asking them to immediately discontinue the marketing of their saliva collection kit and Personal Genome Service (PGS) Kit.
Centralized Review of Investigational Device Exemptions at CMS-An IDEa Whose Time Has Come
Since Avalere last discussed Investigational Device Exemptions (IDEs), IDE regulatory and reimbursement policy landscape at FDA and CMS have issued some predicted changes; FDA has issued new draft guidance documents while CMS included many of these changes in their 2013 proposed physician payment rule.
FDA’s Statement on Proposed Hydrocodone Reclassification
On October 24, Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at FDA, issued a statement indicating the Agency's intent to recommend reclassifying hydrocodone combination products from Schedule III to Schedule II products.