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Biosimilars: BIO Comments on FDA Draft Guidance Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009

Re: Draft Guidance for Industry: Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (Docket No. FDA-2015-D-4750 (March 14,...

Life Sciences Community Joins Rep. Charlie Dent to Discuss State of the Industry and Positive Impact on Pennsylvania

Pennsylvania’s concentration of bioscience employment is nine percent greater than national average

"Imagine" #BIO2016 Buzz Center Recap

Throughout BIO 2016, biopharmaceutical company and government leaders were asked: "Imagine ______".  Here are their answers.

BIO Comments on Medicare Inpatient Prospective Payment System (IPPS) Proposed Rule

BIO submitted comments on the Medicare Inpatient Prospective Payment System (IPPS) Proposed Rule, which focused on several proposals related to, among other things, CMS’s review of New Technology Add-on Applications, the Hospital Value-Based Purchasing Program, the Hospital Inpatient Quality Reporting Program, the PPS-Exempt Cancer Hospital Quality Reporting Program, and the Long-Term Care Hospital Quality Reporting Program.

Biotechnology Innovation Organization and Biominas Brasil to Co-Host BIO Latin America Conference

Meeting will bring together biotechnology executives, academics and investors from around the globe 

New PBS Film and 2016 BIO Animal Biotech Summit Highlight Biotech Solutions to Combating Emerging Infectious Diseases

Programming at this year’s Animal Biotech Summit, Advancing One Health through Biotechnology, will look at how biotechnology can be used in emerging infectious disease surveillance and rapid diagnosis, while highlighting the flexibility biotechnology provides for treating, controlling and preventing these diseases. The 2016 Summit will be held September 21-23, 2016 in Bethesda, Maryland. 

Pennsylvania Governor Wolf Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicines

BIO and Pennsylvania Bio commend Governor Tom Wolf for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians.

Electronic Health Record Data: BIO Comments on FDA Draft Guidance Use of Electronic Health Record Data in Clinical Investigations

Electronic health record (EHR) data and “real world evidence” generated from the post-marketing clinical use of medicines can provide valuable information regarding the use, benefits, or risks of therapies. BIO applauds FDA for taking steps to provide greater clarity around the use of EHR data in clinical assessments of safety and effectiveness in regulatory submissions.

SPA: BIO Comments on Special Protocol Assessment; Draft Guidance for Industry

BIO is supportive of FDA’s efforts to clarify the special protocol assessment (SPA) process for sponsors through the updated draft Special Protocol Assessment guidance, which provides helpful clarification on which protocols are eligible for SPA, as well as other updates and details.

Compounding: BIO Comments on FDA Draft Guidance Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act

BIO applauds the issuance by the FDA of this Draft Guidance as it recognizes the importance of the prescription requirement under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). BIO recognizes that access to medically-needed compounded medicines is highly important; but access cannot and should not come at the expense of product quality and patient safety.