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So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups
…For 510(k) devices, sponsors could wait to establish a quality system that covers all post-market requirements until device development is further along. Waiting too long, however, could lead to delays…
The Good, Bad, and Ugly side of 510(k)s—HP&M’s Early Experience with the eSTAR Template for 510(k)s
…requests in an eCopy format. The eSTAR templates can also be used to respond to requests for additional information. When entering the template, the user can select “additional information” as…
A PSA on PSGs: PSG Meetings Are Now Available
…within 2 years of reference product approval and 75 percent of complex New Chemical Entities within 3 years of approval. FDA also agreed, for the first time, to host PSG…
The Clot Thickens! Bloggers Beware! Congress Requests Information from Drug Rep. Website on Anonymous Postings Concerning Early ENHANCE Study Results
…all records related to the Cafepharma.com postings. In two other letters unrelated to the Cafepharma.com postings, the Oversight and Investigations Subcommittee also requests detailed information from FDA and Merck/Schering-Plough on,…
Makin’ Copies: FDA Revises RLD and RS Guidance
…RS based, among other elements, on “units sold,” but the final guidance revises this factor to “commercial data,” which, again, provides FDA more flexibility to interpret the term “commercial data”…
FDA Launches Digital Health Center of Excellence
…digital health. It appears that the DHCoE provides new organization for the work that the Agency has already been doing in the digital health space. DHCoE services are organized into…
You Don’t Change Horses in Mid-Stream: Product-Specific Guidances
…the PSGs undergoing revision are also assigned a “planned revision category.” The revision categories are “Major Revisions,” “Minor Revisions,” and “Editorial Revisions.” “Major Revisions” are defined as the revision of…
FDA’s Getting Its Priorities Straight: Revised ANDA Priority MAPP
…be eligible for approval at goal date, but that can’t happen until at least 100 days after ANDA submission (60 days for FDA to “receive” the ANDA and 45 days…
HP&M Shares Experience with 16 Externally-Led Patient-Focused Drug Development Meetings; Summarizes Commonalities in Rare Disease Patient Perspectives in Comment to FDA
…perform activities of daily living (ADLs). Further exploration of these commonalities will potentially support future medical product development by informing trial designs and endpoint development that can be used across…
Go for It! (Connect) Paragraph IV! FDA Revamps ANDA Paragraph IV Certifications List
…be able to obtain final approval.” To this end, FDA now plans to include the following information for individual drug products on the Paragraph IV certification list: Active Ingredient Name…
HP&M’s James Valentine Named a 2019 RARE Champion of Hope; Moderates Global Rare Disease Town Hall with FDA and EMA
…having helped secure FDA approval for several new molecular entities in this relatively short period of time. In fact, the Global Genes announcement came just one day before James moderated…
FDA Issues Final Guidance on Postmarketing Safety Reporting for Combination Products
…investigational plan or proposed labeling, is “intended for use only with an approved individually specified drug, device or biological product where both are required to achieve the intended use, indication…
Dust Yourself Off and Try Again: GAO Report On ANDA Approval Shows that Multiple Review Cycles Are Still Often Necessary
…went through subsequent review cycles to obtain approval, potentially delaying approval for years. On average, from 2013 through 2017, it took three review cycles for ANDAs to attain approval. Some…
Here We Go Again: FDA Sued for Failure to Meet Yet Another FSMA Deadline
…an abdication of the agency’s fundamental responsibilities . . . and is putting millions of lives at continued risk from contracting foodborne illnesses, contrary to Congress’ commands.” This is certainly…
FDA’s Latest PFDD Guidance Puts What Is Important to Patients at the Center of Drug Development. How? By Asking Them.
…reporting as if they were the patient), but instead eliciting what caregivers observe in patients, including things patients tell them. Can This Research Be Done on Social Media? The final…