Tag Archives: Biologicals

FDA issues draft guidance for use in product quality assessments

On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted for FDA’s review as part of original new drug applications (NDAs), original biologics license applications (BLAs), or supplements to … Continue Reading

FDA Issues New Draft Guidance and Related Proposed Rule on Naming Biological Products

On August 28, 2015 the federal Food and Drug Administration (“FDA”) issued two important policies regarding naming biological products, including biosimilars. First, FDA released a notice announcing the availability of draft guidance entitled “Nonproprietary Naming of Biological Products.” The draft guidance highlights FDA’s current thinking on the need for biological products licensed under the Public … Continue Reading

FDA Releases “Purple Book,” Including Biosimilar Products

The FDA’s new “Purple Book” lists biological products licensed by FDA under the Public Health Service Act (the PHS Act). The publication includes information on whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act, and whether the FDA has determined a biological product to be biosimilar to … Continue Reading

FDA Meeting on Biomarker Development (Sept. 5)

On September 5, 2014, the FDA is holding a public meeting at the Washington Plaza Hotel, in Washington DC, to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in the development of therapeutic products (e.g., drugs and biologics). Specifically, FDA will focus on (1) identifying challenges for biomarker applications in early- … Continue Reading

FDA Draft Guidance on Biosimilar Product Development Now Available

A new draft guidance document on formal meetings between the FDA and biosimilar biological sponsors is now available from FDA. The draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products. Further, the draft guidance assists sponsors and applicants in generating … Continue Reading

FDA Issues New Guidance Documents

In recent weeks, the Food and Drug Administration (FDA) has issued a number of new draft and final guidance documents on a range of issues, including financial disclosure by clinical investigators, medical device recalls, prescription drug labeling, and medical devices for pediatric uses. Highlights include the following: Financial Disclosure by Clinical Investigators. This final guidance … Continue Reading

FDA Issues Final Rule on Current Good Manufacturing Practice Requirements for Combination Products

FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. The rule clarifies which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. For certain types of combination products the application of CGMP requirements is straightforward – the constituent parts of … Continue Reading

New FDA Draft Guidance Addresses Combination Product Postapproval Modification Submissions

FDA has issued a new draft guidance document entitled “Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA.” The document provides guidance to industry and FDA staff on the underlying principles to determine the type of marketing submission that may be required for postapproval changes to a combination product … Continue Reading

FDA Issues Final Rule on Sterility Testing of Biological Products

This post was written by Erin A. Janssen. On May 3, 2012 the FDA issued its final rule on sterility testing, amending the requirements for most licensed biological products effective June 4, 2012.  The rule is intended to promote improvement and innovation in the development of sterility test methods by allowing manufacturers the flexibility needed … Continue Reading

FDA Announces Review of Bar Code Final Rule

This post was written by Erin Janssen. The Food and Drug Administration (FDA) has published a notice announcing that it will conduct a review of its 2004 ‘‘Bar Code Final Rule,” which requires certain human drug products and biological products to have a bar code. The rule was intended to help reduce the number of medication … Continue Reading

President Issues Executive Order Regarding Drug Shortages

This post was written by Erin Janssen. On October 31, 2011, President Obama signed an Executive Order directing the FDA to take action to help further prevent and reduce prescription drug shortages, protect consumers, and prevent price gouging. The President’s order directs FDA to broaden reporting of potential shortages of certain prescription drugs and to further … Continue Reading

FDA Proposes Amendments to Orphan Drug Rules

The Food and Drug Administration (FDA) published a proposed rule on October 19, 2011 that would amend the 1992 Orphan Drug Regulations that implement the Orphan Drug Act. The amendments proposed are “intended to assist sponsors who are seeking and who have obtained orphan drug designation of their drugs, as well as FDA in administering … Continue Reading

FDA Issues Final Guidance on Risk Labeling for Prescription Drugs and Biological Products

This post was written by Erin Janssen and Areta Kupchyk.  On October 12, 2011 the FDA announced the availability of guidance for the industry entitled “Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products–Content and Format.” This guidance is intended to assist applicants and reviewers in drafting the … Continue Reading

FDA Guidance on Reproductive and Developmental Toxicities

This post was written by Erin Janssen and Areta Kupchyk. On September 23, 2011, FDA released guidance entitled “Reproductive and Developmental Toxicities–Integrating Study Results to Assess Concerns.” The guidance describes an approach to estimating possible human developmental or reproductive risks associated with drug or biological product exposure when a finding of toxicity has been identified, but … Continue Reading

FDA Proposed Rule to Amend Sterility Test Requirements for Biologicals

This post was written by Erin A. Janssen. On June 21, 2011, the Food and Drug Administration (FDA) published a proposed rule that would amend current sterility test requirements for biological products to provide manufacturers with greater flexibility and to encourage use of the most appropriate and state-of-the-art test methods for assuring the safety of biologicals. Comments … Continue Reading

President Obama Outlines Plans for Deficit Reduction/Entitlement Reform

On April 13, 2011, President Obama delivered a speech outlining his plan for reducing the federal budget deficit by $4 trillion within 12 years, in part through Medicare and Medicaid reforms. Specifically, the President is calling for $480 billion in Medicare and Medicaid cuts by 2023 and at least an additional $1 trillion in cuts over … Continue Reading

FDA Releases Guidance Document on Process Validation

This post was written by Paul Sheives. FDA has issued a final guidance document entitled “Process Validation: General Principles and Practices,” which replaces FDA’s 1987 “Guideline on General Principles of Process Validation.” The guidance is intended to outline the general principles and appropriate elements of process validation for the manufacture of human and animal drug … Continue Reading

Memorandum of Understanding Between FDA and CMS

This post was written by Paul Sheives and Areta Kupchyk. The FDA and CMS have entered into a Memorandum of Understanding (MOU), effective June 25, 2010, to promote collaboration and enhance knowledge and efficiency by sharing information and expertise. In particular, the MOU highlights the agencies’ “common needs for evaluating the safety, efficacy, utilization, coverage, payment, … Continue Reading

FDA Meeting on Risk Evaluation and Mitigation Strategies (July 27-28)

This post was written by Paul Sheives. FDA will hold a 2-day public meeting on July 27 and 28, 2010 to address the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs and biological products. The purpose of the meeting is to seek public input on various concerns that stakeholders have raised … Continue Reading

FDA to Post New On-line Information Regarding Safety Monitoring Issues for Recently-Approved Drugs and Biologics

This post was written by Paul Sheives. FDA announced a new initiative, required under the Food and Drug Administration Amendments Act of 2007, to post summaries of FDA safety analyses and the agency’s plan to address them on the FDA website. Because evidence of some side effects arises following approval of the products, FDA is … Continue Reading

FDA Review of Articles for Treatment of Rare Diseases

FDA is hosting a meeting June 29 and 30 on “FDA Review and Regulation of Articles for the Treatment of Rare Diseases.” The hearing is intended to provide stakeholders, including the pharmaceutical industry, with an opportunity to present their views on the way FDA regulates the scientific evaluation of, marketing authorization for, and postmarket surveillance of, … Continue Reading

CMS Transmittals on Discarded, Self-Administered Drugs/Biologicals

CMS has issued a Medicare Claims Processing Manual update regarding discarded drugs and biologicals, including language regarding use of the JW modifier (“Drug or Biological Amount Discarded/Not Administered to Any Patient”). The manual update is effective July 30, 2010. In addition, CMS has updated its manual language relating to Determining Self Administration of Drug or Biological. Due to … Continue Reading

Proposed Rule Amending Informed Consent Disclosure

This post was written by Paul Sheives. On December 29, 2009, the Food & Drug Administration Act (FDA) issued a proposed rule that would amend the informed consent regulations to require the addition of an element regarding disclosure of information to the National Institute of Health (NIH) clinical trials database. Under the Food and Drug Administration … Continue Reading

FDA Guidance Documents

This post was written by Paul Sheives. FDA recently released two guidance documents (one in draft form) concerning hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C), which provide information to manufacturers seeking licensure and potential sponsors for Investigational New Drugs Applications (INDs). FDA announced that it no longer intends to exercise enforcement … Continue Reading