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At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub
…medical product centers. This individual will play a key role in overseeing the new integrated Hub model and helping to develop and implement its strategic agenda action plan. Implementation of…
FSIS Proposes Rule Concerning Recall Procedures
…be incorporated into the establishment’s Hazard Analysis and Critical Control Points (“HACCP”) plan. The proposed rule also includes a requirement for written records of annual reviews/reassessments of the establishment’s HACCP…
HHS Issues Final Conflict of Interest Rules for PHS-Funded Research That Increases Burden to Institutions and Investigators
…National Institutes of Health (“NIH”)) in response to congressional and public concerns over potential conflicts between investigators and companies, such as drug and medical device manufacturers. The final rules implement…
PLAN B Revisited: FDA Rules on One-Step Exclusivity and ANDA Labeling Carve-Outs
…3-year exclusivity because it is approved based on new clinical studies that are essential to approval conducted by or for the applicant and the same applicant subsequently obtains approval of…
As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List Grows
…area of tobacco sales and market dynamics. The Committee recommends FDA’s Office of Criminal Investigations assist Federal, state, and local agencies in targeting the highest-level criminal tobacco trafficking organizations by…
Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations Bills
…TCA’s national minimum purchase age of 18 years to all tobacco products, regardless of when all other aspects of the deeming rule are made final. Further, the Committee urges the…
Highlights of Drug and Biologic Related Provisions of 21st Century Cures (Part Two)
…technical, and professional personnel. Section 3072 amends the FDC Act by allowing FDA to appoint scientific, technical, or professional positions that support the development, review, and regulation of medical products…
A Few More Steps in FDA’s Drug Competition Action Plan
As a prelude to FDA’s Hatch-Waxman Act public meeting next month, FDA announced today an updated a Manual of Policy and Procedures (MAPP) for review of generic drug applications and…
Recent Developments in the Medicaid Drug Rebate Program
…2020, CMS published a final rule making several changes to the MDRP regulations. See our post here and our summary of the final rule here. One of these amendments was…
Higher Medicaid Rebates Will Help to Fund COVID Rescue Plan
…and treatments, without cost sharing, for all eligible beneficiaries during the public health emergency and for one year after it ends. Sec. 9811(a)(1), (2). The legislation also makes clear that…
Updates to FDA’s Software Pre-Certification Program
…real world.” Working Model at 7. The details of the Pre-Cert Program are outlined in the Working Model. The first notable change to the Working Model is the introduction of…
A Final LDT Rule in April!? Will FDA be Prepared?
…of new scientific and technical professional fields, and fewer candidates with a hybrid of specialties have resulted in hiring delays for the MDUFA program.”[22] The “competition” for these candidates will…
FDA Issues a Draft Guidance for Content of Premarket Submissions for Device Software Functions
…devices categorized as Basic level, but for sponsors of devices in the Enhanced level, they need to also provide unit and integration level test protocols and results. The Agency added…
Never Stop Never Stopping: More Questions About the BPCIA Continue to Arise
…of what actually constitutes such notice. Amgen filed a redacted copy of its revised opening brief in Amgen v. Hospira, Case 1:15-cv-00839 (D. Del.), supporting a motion for preliminary injunction…
PhRMA Sues Arkansas for Meddling in the Federal 340B Drug Discount Program
…in federal court are AstraZeneca Pharmaceuticals v. Becerra, No. 1:21-cv-00027-LPS, 2021 WL 2458063 (D. Del. Jan. 12, 2021); Eli Lilly & Co. v. Cochran, No. 1:21-cv-00081-SEB-MJD (S.D. Ind. Jan. 12,…